{ "report_title": "FDA Warning Letter Compliance Intelligence Report", "generated_at": "2026-04-17T16:46:42.470444", "ai_model": "anthropic/claude-opus-4.6", "summary": { "total_letters": 224, "analyzed_letters": 224, "unanalyzed_letters": 0, "total_deficiencies": 1152, "unique_companies": 219, "average_risk_score": 91.8, "date_range": "2021-2026" }, "risk_score_distribution": { "critical_90_100": 170, "high_75_89": 53, "medium_50_74": 1, "low_0_49": 0 }, "severity_distribution": { "critical": 966, "major": 185, "minor": 1 }, "top_cited_clauses": [ { "clause": "21 CFR 820.100(a)", "count": 66 }, { "clause": "21 CFR 820.30(g)", "count": 44 }, { "clause": "21 CFR 820.75(a)", "count": 42 }, { "clause": "21 CFR 820.198(a)", "count": 37 }, { "clause": "21 CFR 820.30(a)", "count": 22 }, { "clause": "21 CFR 820.50", "count": 21 }, { "clause": "21 CFR 820.90(a)", "count": 21 }, { "clause": "21 CFR 803.17", "count": 19 }, { "clause": "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "count": 16 }, { "clause": "21 CFR 820.184", "count": 15 }, { "clause": "21 CFR 820.30(i)", "count": 13 }, { "clause": "21 CFR 820.22", "count": 13 }, { "clause": "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "count": 12 }, { "clause": "21 CFR 820.100(a)(1)", "count": 11 }, { "clause": "21 CFR 820.198(c)", "count": 10 }, { "clause": "21 CFR 820.30(c)", "count": 10 }, { "clause": "21 CFR 820.80(a)", "count": 10 }, { "clause": "21 CFR 820.30(f)", "count": 8 }, { "clause": "21 CFR 820.80(d)", "count": 8 }, { "clause": "21 CFR 803.50(a)(2)", "count": 8 } ], "top_qmsr_clauses": [ { "clause": "ISO 13485:2016 Clause 8.5.2 / 8.5.3", "count": 45 }, { "clause": "ISO 13485:2016 Clause 8.2.2", "count": 45 }, { "clause": "ISO 13485:2016 Clause 7.5.6", "count": 35 }, { "clause": "ISO 13485:2016 Clause 8.2.3 (Reporting to Regulatory Authorities)", "count": 30 }, { "clause": "ISO 13485:2016 Clause 7.3", "count": 27 }, { "clause": "ISO 13485:2016 Clause 8.2.3", "count": 22 }, { "clause": "ISO 13485:2016 Clause 8.3", "count": 19 }, { "clause": "ISO 13485:2016 Clause 8.2.2 (Complaint Handling)", "count": 16 }, { "clause": "N/A - Premarket Authorization Requirement", "count": 16 }, { "clause": "ISO 13485:2016 Clause 7.3.9", "count": 13 }, { "clause": "N/A - Premarket Notification Requirement", "count": 13 }, { "clause": "N/A - Premarket regulatory requirement", "count": 12 }, { "clause": "ISO 13485:2016 Clause 8.2.4", "count": 11 }, { "clause": "ISO 13485:2016 Clause 7.4", "count": 11 }, { "clause": "ISO 13485:2016 Clause 7.5.8", "count": 11 }, { "clause": "ISO 13485:2016 Clause 7.3.6", "count": 10 }, { "clause": "ISO 13485:2016 Clause 8.5.2", "count": 10 }, { "clause": "ISO 13485:2016 Clause 7.4 (Purchasing)", "count": 9 }, { "clause": "ISO 13485:2016 Clause 7.5.1", "count": 9 }, { "clause": "ISO 13485:2016 Clause 8.5.2 (Corrective Action) and 8.5.3 (Preventive Action)", "count": 8 } ], "co_occurrence_patterns": [ { "clause_a": "ISO 13485:2016 Clause 7.3", "clause_b": "ISO 13485:2016 Clause 8.2.2", "count": 17 }, { "clause_a": "ISO 13485:2016 Clause 8.2.2", "clause_b": "ISO 13485:2016 Clause 8.5.2 / 8.5.3", "count": 16 }, { "clause_a": "ISO 13485:2016 Clause 7.5.6", "clause_b": "ISO 13485:2016 Clause 8.5.2 / 8.5.3", "count": 14 }, { "clause_a": "ISO 13485:2016 Clause 7.3", "clause_b": "ISO 13485:2016 Clause 7.5.6", "count": 13 }, { "clause_a": "N/A - Premarket Authorization Requirement", "clause_b": "N/A - Premarket Notification Requirement", "count": 12 }, { "clause_a": "ISO 13485:2016 Clause 7.5.6", "clause_b": "ISO 13485:2016 Clause 8.3", "count": 11 }, { "clause_a": "ISO 13485:2016 Clause 8.2.2", "clause_b": "ISO 13485:2016 Clause 8.2.3", "count": 11 }, { "clause_a": "ISO 13485:2016 Clause 7.5.6", "clause_b": "ISO 13485:2016 Clause 8.2.2", "count": 11 }, { "clause_a": "ISO 13485:2016 Clause 7.3", "clause_b": "ISO 13485:2016 Clause 8.5.2 / 8.5.3", "count": 11 }, { "clause_a": "ISO 13485:2016 Clause 8.2.2", "clause_b": "ISO 13485:2016 Clause 8.3", "count": 10 }, { "clause_a": "ISO 13485:2016 Clause 7.3", "clause_b": "ISO 13485:2016 Clause 7.4", "count": 10 }, { "clause_a": "ISO 13485:2016 Clause 8.3", "clause_b": "ISO 13485:2016 Clause 8.5.2 / 8.5.3", "count": 10 }, { "clause_a": "ISO 13485:2016 Clause 7.3.9", "clause_b": "ISO 13485:2016 Clause 8.2.2", "count": 10 }, { "clause_a": "ISO 13485:2016 Clause 7.3", "clause_b": "ISO 13485:2016 Clause 8.3", "count": 9 }, { "clause_a": "ISO 13485:2016 Clause 7.4", "clause_b": "ISO 13485:2016 Clause 8.2.2", "count": 8 } ], "category_co_occurrence": [ { "category_a": "Design Controls", "category_b": "Other", "count": 89 }, { "category_a": "Complaint Files", "category_b": "Design Controls", "count": 69 }, { "category_a": "CAPA", "category_b": "Design Controls", "count": 56 }, { "category_a": "Complaint Files", "category_b": "Other", "count": 45 }, { "category_a": "CAPA", "category_b": "Complaint Files", "count": 41 }, { "category_a": "Design Controls", "category_b": "Process Validation", "count": 32 }, { "category_a": "Management Responsibility", "category_b": "Other", "count": 31 }, { "category_a": "Design Controls", "category_b": "Purchasing Controls", "count": 30 }, { "category_a": "CAPA", "category_b": "MDR Reporting", "count": 30 }, { "category_a": "CAPA", "category_b": "Process Validation", "count": 29 }, { "category_a": "Design Controls", "category_b": "Management Responsibility", "count": 29 }, { "category_a": "Complaint Files", "category_b": "MDR Reporting", "count": 26 }, { "category_a": "Design Controls", "category_b": "MDR Reporting", "count": 26 }, { "category_a": "Design Controls", "category_b": "Quality Audit", "count": 24 }, { "category_a": "Complaint Files", "category_b": "Management Responsibility", "count": 23 }, { "category_a": "Design Controls", "category_b": "Document Controls", "count": 23 }, { "category_a": "CAPA", "category_b": "Other", "count": 22 }, { "category_a": "Complaint Files", "category_b": "Purchasing Controls", "count": 21 }, { "category_a": "Other", "category_b": "Process Validation", "count": 20 }, { "category_a": "CAPA", "category_b": "Quality Audit", "count": 20 }, { "category_a": "Document Controls", "category_b": "Other", "count": 20 }, { "category_a": "CAPA", "category_b": "Purchasing Controls", "count": 19 }, { "category_a": "Design Controls", "category_b": "Nonconforming Product", "count": 19 }, { "category_a": "Complaint Files", "category_b": "Process Validation", "count": 18 }, { "category_a": "CAPA", "category_b": "Nonconforming Product", "count": 17 } ], "category_letter_coverage": [ { "category": "Design Controls", "letters": 153, "pct_of_letters": 68.3 }, { "category": "Other", "letters": 120, "pct_of_letters": 53.6 }, { "category": "Complaint Files", "letters": 89, "pct_of_letters": 39.7 }, { "category": "CAPA", "letters": 81, "pct_of_letters": 36.2 }, { "category": "Process Validation", "letters": 51, "pct_of_letters": 22.8 }, { "category": "MDR Reporting", "letters": 46, "pct_of_letters": 20.5 }, { "category": "Management Responsibility", "letters": 40, "pct_of_letters": 17.9 }, { "category": "Purchasing Controls", "letters": 39, "pct_of_letters": 17.4 }, { "category": "Quality Audit", "letters": 31, "pct_of_letters": 13.8 }, { "category": "Nonconforming Product", "letters": 29, "pct_of_letters": 12.9 }, { "category": "Document Controls", "letters": 27, "pct_of_letters": 12.1 }, { "category": "Production & Process Controls", "letters": 23, "pct_of_letters": 10.3 }, { "category": "Device History Record", "letters": 18, "pct_of_letters": 8.0 }, { "category": "Records", "letters": 14, "pct_of_letters": 6.2 }, { "category": "Personnel", "letters": 11, "pct_of_letters": 4.9 }, { "category": "Acceptance Activities", "letters": 6, "pct_of_letters": 2.7 }, { "category": "Servicing", "letters": 3, "pct_of_letters": 1.3 }, { "category": "Quality System Record", "letters": 3, "pct_of_letters": 1.3 }, { "category": "Traceability", "letters": 2, "pct_of_letters": 0.9 }, { "category": "Statistical Techniques", "letters": 1, "pct_of_letters": 0.4 }, { "category": "Distribution", "letters": 1, "pct_of_letters": 0.4 }, { "category": "Installation", "letters": 1, "pct_of_letters": 0.4 } ], "deficiency_categories": [ { "category": "Design Controls", "count": 271 }, { "category": "Other", "count": 262 }, { "category": "CAPA", "count": 105 }, { "category": "Complaint Files", "count": 103 }, { "category": "MDR Reporting", "count": 67 }, { "category": "Process Validation", "count": 63 }, { "category": "Management Responsibility", "count": 49 }, { "category": "Purchasing Controls", "count": 44 }, { "category": "Quality Audit", "count": 40 }, { "category": "Nonconforming Product", "count": 30 }, { "category": "Document Controls", "count": 30 }, { "category": "Production & Process Controls", "count": 25 }, { "category": "Device History Record", "count": 18 }, { "category": "Records", "count": 16 }, { "category": "Personnel", "count": 11 }, { "category": "Acceptance Activities", "count": 6 }, { "category": "Traceability", "count": 3 }, { "category": "Quality System Record", "count": 3 }, { "category": "Servicing", "count": 3 }, { "category": "Statistical Techniques", "count": 1 }, { "category": "Distribution", "count": 1 }, { "category": "Installation", "count": 1 } ], "common_root_causes": [ { "cause": "no quality management system or regulatory compliance infrastructure in place", "count": 3 }, { "cause": "no premarket regulatory strategy or submission process in place", "count": 3 }, { "cause": "absence of management responsibility and commitment to regulatory compliance", "count": 3 }, { "cause": "no management responsibility or organizational commitment to regulatory compliance", "count": 3 }, { "cause": "complete absence of a quality management system (qms) for medical device manufacturing and distribution", "count": 3 }, { "cause": "lack of management responsibility and commitment to regulatory compliance", "count": 2 }, { "cause": "fundamental lack of understanding of fda regulatory requirements for marketing medical devices in the united states", "count": 2 }, { "cause": "fundamental lack of understanding of fda regulatory requirements for medical device marketing, including premarket notification (510(k)) and premarket approval (pma) pathways", "count": 2 }, { "cause": "no establishment registration or device listing with fda", "count": 2 }, { "cause": "fundamental lack of understanding of fda regulatory requirements for medical devices, including premarket notification (510(k)), pma, and eua pathways", "count": 2 }, { "cause": "no labeling review or approval process to ensure accuracy of regulatory claims on website and promotional materials", "count": 2 }, { "cause": "complete absence of a quality management system for medical device manufacturing and distribution", "count": 2 }, { "cause": "complete absence of a quality management system \u2014 no evidence of any qms infrastructure, design controls, or regulatory compliance processes", "count": 2 }, { "cause": "complete absence of fda regulatory awareness and compliance infrastructure \u2014 the firm appears to have no understanding of u.s. medical device regulatory requirements", "count": 2 }, { "cause": "systemic disconnect between risk management outputs (dfmea severity ratings) and capa risk assessments (hhe), leading to corrective actions that are not commensurate with actual risk to patients and users", "count": 1 } ], "year_distribution": { "2021": 63, "2022": 25, "2023": 36, "2024": 45, "2025": 46, "2026": 9 }, "device_class_distribution": { "II": 66, "I": 12, "III": 4 }, "per_company_detail": [ { "company": "LEVO AG", "letter_id": "levo-ag-717287", "date": "2025-07-18", "device": "", "risk_score": 98, "deficiency_count": 31, "top_clauses": [ "21 CFR 820.5", "21 CFR 820.20", "21 CFR 820.22", "21 CFR 820.25", "21 CFR 820.30", "21 CFR 820.40", "21 CFR 820.50", "21 CFR 820.60", "21 CFR 820.65", "21 CFR 820.70", "21 CFR 820.72", "21 CFR 820.75", "21 CFR 820.80", "21 CFR 820.86", "21 CFR 820.90", "21 CFR 820.100", "21 CFR 820.120", "21 CFR 820.130", "21 CFR 820.140", "21 CFR 820.150", "21 CFR 820.160", "21 CFR 820.170", "21 CFR 820.180", "21 CFR 820.181", "21 CFR 820.184", "21 CFR 820.186", "21 CFR 820.198", "21 CFR 820.200", "21 CFR 820.250", "21 CFR 803.17", "21 CFR 830.300" ] }, { "company": "Tesla BioHealing, Inc.", "letter_id": "tesla-biohealing-inc-658010", "date": "2023-08-10", "device": "", "risk_score": 98, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the Act / 21 CFR 807.81(b)", "21 CFR 820.30(g)", "21 CFR 820.20(e)", "21 CFR 820.198(a)", "21 CFR 820.100(a)" ] }, { "company": "North American Diagnostics, LLC", "letter_id": "north-american-diagnostics-llc-643203", "date": "2022-12-27", "device": "SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen T", "risk_score": 98, "deficiency_count": 10, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.70", "21 CFR 820.75(a)", "21 CFR 820.80", "21 CFR 820.100(a)", "21 CFR 820.160(a)", "21 CFR 820.198(a)", "21 CFR 820.20(b)", "21 CFR 803.17", "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k)" ] }, { "company": "RoyalVibe Health Ltd.", "letter_id": "royalvibe-health-ltd-639553", "date": "2022-11-18", "device": "CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls", "risk_score": 98, "deficiency_count": 9, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 Premarket Notification", "21 U.S.C. \u00a7 360j(g) / Section 520(g) of the FD&C Act \u2014 Investigational Device Exemption (IDE)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act \u2014 Misbranding", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2014 Adulteration", "21 CFR 807 \u2014 Establishment Registration and Device Listing", "21 CFR 820 (Quality System Regulation) / Entire Subparts", "21 CFR 820.198 / Complaint Handling and Post-Market Surveillance", "21 CFR 803 \u2014 Medical Device Reporting (MDR)" ] }, { "company": "USA Medical LLC", "letter_id": "usa-medical-llc-631500", "date": "2022-08-03", "device": "Diagnostic Kit SARS-cCo V Antigen Rapid Test", "risk_score": 98, "deficiency_count": 15, "top_clauses": [ "21 CFR 820.80(a)", "21 CFR 820.90(a)", "21 CFR 820.160(a)", "21 CFR 820.50", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.70(c)", "21 CFR 820.140", "21 CFR 820.22", "21 CFR 820.20(c)", "21 CFR 820.25(b)", "21 CFR 820.20(a)", "21 CFR 803.17", "Section 501(f)(1)(B) of the FD&C Act / 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 502(a) of the FD&C Act / 21 U.S.C. \u00a7 352(a)" ] }, { "company": "Lusys Laboratories, Inc.", "letter_id": "lusys-laboratories-inc-625807", "date": "2022-02-17", "device": "Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vi", "risk_score": 98, "deficiency_count": 3, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the FD&C Act) / 21 U.S.C. \u00a7 360(k) (Section 510(k) of the FD&C Act)", "21 U.S.C. \u00a7 352(o) (Section 502(o) of the FD&C Act) / 21 CFR Part 807 Subpart E", "21 U.S.C. \u00a7 331(a) and 331(k) (Sections 301(a) and 301(k) of the FD&C Act)" ] }, { "company": "Anytime COVID Test LLC", "letter_id": "anytime-covid-test-llc-611366", "date": "2021-04-13", "device": "", "risk_score": 98, "deficiency_count": 5, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 510(k) of the FD&C Act, 21 U.S.C. \u00a7 360(k); Section 502(o) of the Act, 21 U.S.C. \u00a7 352(o)", "Section 502(a) of the FD&C Act, 21 U.S.C. \u00a7 352(a)", "Section 301(a) and 301(k) of the FD&C Act, 21 U.S.C. \u00a7 331(a) and \u00a7 331(k)", "21 CFR Part 807 (Establishment Registration and Device Listing); FDA Logo Policy" ] }, { "company": "Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs", "letter_id": "tresmonet-technologies-inc-tm-testing-inc-dba-tm-technologies-inctm-labs-610158", "date": "2021-03-24", "device": "", "risk_score": 98, "deficiency_count": 5, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B) \u2014 Adulteration (No PMA/510(k)/EUA)", "Section 502(o) of the FD&C Act, 21 U.S.C. \u00a7 352(o) \u2014 Misbranding (Failure to submit 510(k))", "Section 502(a) of the FD&C Act, 21 U.S.C. \u00a7 352(a) \u2014 Misbranding (False and misleading labeling)", "Section 301(a) and 301(k) of the FD&C Act, 21 U.S.C. \u00a7 331(a) and \u00a7 331(k) \u2014 Prohibited acts", "21 CFR Part 809 \u2014 In Vitro Diagnostic Products (implied); FDA COVID-19 EUA Policy" ] }, { "company": "SeniorLife Technologies, Inc.", "letter_id": "seniorlife-technologies-inc-707021", "date": "2025-08-21", "device": "", "risk_score": 97, "deficiency_count": 7, "top_clauses": [ "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k) / Section 515(a) of the Act, 21 U.S.C. \u00a7 360e(a)", "21 CFR \u00a7 820.100(a)", "21 CFR \u00a7 820.198(a)", "21 CFR \u00a7 820.22", "21 CFR \u00a7 820.25(b)", "21 CFR \u00a7 803.17", "Section 502(a) of the Act, 21 U.S.C. \u00a7 352(a)" ] }, { "company": "Microspecialties, LLC", "letter_id": "microspecialties-llc-707614", "date": "2025-05-08", "device": "Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:", "risk_score": 97, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.80(d)", "21 CFR 820.75(a)", "21 CFR 820.250(b)" ] }, { "company": "United Health Products, Inc.", "letter_id": "united-health-products-inc-697777", "date": "2025-03-24", "device": "", "risk_score": 97, "deficiency_count": 3, "top_clauses": [ "21 CFR 812.20(a)(1) and (2)", "21 CFR 812.40", "21 CFR 812.46(a)" ] }, { "company": "Becton, Dickinson, and Company/CareFusion 303, Inc.", "letter_id": "becton-dickinson-and-companycarefusion-303-inc-691601", "date": "2024-11-22", "device": "BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.", "risk_score": 97, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.30(g)", "21 CFR 803.50(a)(2)" ] }, { "company": "Optikem International, Inc.", "letter_id": "optikem-international-inc-683606", "date": "2024-08-13", "device": "", "risk_score": 97, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.75", "21 CFR 820.72", "21 CFR 820.30", "21 CFR 820.100", "21 CFR 807.81(a)(3)(i) / Section 510(k) / Section 515(a) PMA" ] }, { "company": "Edge Biologicals Inc.", "letter_id": "edge-biologicals-inc-660003", "date": "2023-06-27", "device": "Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the ", "risk_score": 97, "deficiency_count": 8, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.100(a)", "21 CFR 820.50(a)", "21 CFR 820.181", "21 CFR 820.70(c)", "21 CFR 820.80(a)", "21 CFR 820.22", "21 CFR 820.25(a)" ] }, { "company": "ZYTO Technologies, Inc.", "letter_id": "zyto-technologies-inc-652316", "date": "2023-06-21", "device": "The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline origin", "risk_score": 97, "deficiency_count": 7, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) \u2014 Premarket Approval (PMA) / 510(k)", "Section 502(o) of the FD&C Act, 21 U.S.C. 352(o) \u2014 510(k) Notification (21 CFR 807.81)", "21 CFR 820.30 (Design Controls)", "21 CFR 820.30(f) (Design Verification)", "21 CFR 820.30(g) (Design Validation)", "21 CFR 820.30 \u2014 Software as a Component", "21 CFR 820.30 \u2014 Virtual Item Library Development" ] }, { "company": "Synovo Production, Inc.", "letter_id": "synovo-production-inc-647427", "date": "2023-03-23", "device": "Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042\t01-03-0044\t01-03-0045\t01-03-0047\t01-03-0049\t01-03-0051\t01-03-0052", "risk_score": 97, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.30(a)", "21 CFR 820.100(a)", "21 CFR 820.50", "21 CFR 820.20(c)", "21 CFR 820.22", "21 CFR 820.25(b)", "21 CFR 807.81(a)(3) / Section 510(k)", "Section 515(a) / 21 CFR 888.3410" ] }, { "company": "Wintech Medipro LLC", "letter_id": "wintech-medipro-llc-640048", "date": "2022-11-16", "device": "", "risk_score": 97, "deficiency_count": 9, "top_clauses": [ "21 CFR 803.17", "21 CFR 820.30(a)", "21 CFR 820.75(a)", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.90(a)", "21 CFR 820.80(a)", "21 CFR 820.50", "21 CFR 820.22" ] }, { "company": "Medtronic, Inc.", "letter_id": "medtronic-inc-617539", "date": "2021-12-09", "device": "Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix", "risk_score": 97, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.100(a) (Risk Management Process)" ] }, { "company": "USH Diagnostics, Inc./covidinstanttest.net", "letter_id": "ush-diagnostics-inccovidinstanttestnet-612084", "date": "2021-07-09", "device": "", "risk_score": 97, "deficiency_count": 5, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 502(o) of the FD&C Act, 21 U.S.C. \u00a7 352(o); Section 510(k), 21 U.S.C. \u00a7 360(k)", "Section 502(a) of the FD&C Act, 21 U.S.C. \u00a7 352(a)", "Section 301(a) and 301(k) of the FD&C Act, 21 U.S.C. \u00a7 331(a) and \u00a7 331(k)", "21 CFR Part 809 (In Vitro Diagnostic Products for Human Use)" ] }, { "company": "Biopolygen Corp.", "letter_id": "biopolygen-corp-613137", "date": "2021-07-09", "device": "", "risk_score": 97, "deficiency_count": 4, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act (21 U.S.C. \u00a7 351(f)(1)(B))", "Section 502(o) of the FD&C Act (21 U.S.C. \u00a7 352(o)); Section 510(k) of the Act (21 U.S.C. \u00a7 360(k))", "Section 301(a) and 301(k) of the FD&C Act (21 U.S.C. \u00a7 331(a), \u00a7 331(k))", "21 CFR 809 (IVD Labeling); Section 201(h) of the FD&C Act (21 U.S.C. \u00a7 321(h))" ] }, { "company": "Tianjin Bolang Science-Technology Development Co., Ltd.", "letter_id": "tianjin-bolang-science-technology-development-co-ltd-614851", "date": "2021-06-17", "device": "", "risk_score": 97, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.160", "21 CFR 820.181", "21 CFR 820.184", "21 CFR 820.186", "21 CFR 820.25(a)", "21 CFR 803.17" ] }, { "company": "Innova Medical Group, Inc.", "letter_id": "innova-medical-group-inc-614819", "date": "2021-06-10", "device": "COVID-19 Self-Test Kit *** INNOVA *** 3T", "risk_score": 97, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.160(a)", "21 CFR 820.80(a)", "21 CFR 820.90(a)", "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k) / Section 515(a) of the Act, 21 U.S.C. \u00a7 360e(a)", "Section 502(a) of the Act, 21 U.S.C. \u00a7 352(a)" ] }, { "company": "Fast Masks USA LLC", "letter_id": "fast-masks-usa-llc-612088", "date": "2021-03-26", "device": "", "risk_score": 97, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2014 Premarket Approval (PMA) / 510(k) Requirements", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 Premarket Notification", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act \u2014 Misbranding (False or Misleading Labeling)", "21 U.S.C. \u00a7 331(a) and 331(k) / Sections 301(a) and 301(k) of the FD&C Act \u2014 Prohibited Acts", "21 CFR Part 809 \u2014 In Vitro Diagnostic Products for Human Use (Distribution Controls)" ] }, { "company": "Ikcon Investments, Inc dba Ikcon Medical", "letter_id": "ikcon-investments-inc-dba-ikcon-medical-609791", "date": "2021-03-25", "device": "", "risk_score": 97, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 CFR 807 (Subpart E - Premarket Notification 510(k))", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act; 21 CFR 807.39", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act", "21 U.S.C. \u00a7 331(k) / Section 301(k) of the FD&C Act", "21 CFR 807 (Establishment Registration and Device Listing)" ] }, { "company": "Technological Medical Advancements LLC", "letter_id": "technological-medical-advancements-llc-712715", "date": "2025-09-26", "device": "", "risk_score": 96, "deficiency_count": 5, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B); Section 510(k), 21 U.S.C. \u00a7 360(k); Section 515(a), 21 U.S.C. \u00a7 360e(a)", "21 CFR 820.50", "21 CFR 820.30" ] }, { "company": "CellEra LLC", "letter_id": "cellera-llc-618209", "date": "2021-10-20", "device": "20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box", "risk_score": 96, "deficiency_count": 8, "top_clauses": [ "21 CFR \u00a7 820.100", "21 CFR \u00a7 820.30", "21 CFR \u00a7 820.30(i)", "21 CFR \u00a7 820.50", "21 CFR \u00a7 820.80(b)", "21 CFR \u00a7 820.198", "21 CFR \u00a7 820.40", "21 CFR \u00a7 820.70(c)" ] }, { "company": "Longhorn Vaccines and Diagnostics LLC", "letter_id": "longhorn-vaccines-and-diagnostics-llc-721702", "date": "2026-02-26", "device": "", "risk_score": 95, "deficiency_count": 13, "top_clauses": [ "21 CFR 820.198(a), 21 CFR 820.198(a)(1) through (a)(3)", "21 CFR 820.198(b)", "21 CFR 820.198(c)", "21 CFR 820.100(a), 21 CFR 820.100(a)(1) through (a)(4)", "21 CFR 820.30(a)", "21 CFR 820.30(b)", "21 CFR 820.30(c)", "21 CFR 820.30(d)", "21 CFR 820.30(e)", "21 CFR 820.30(f)", "21 CFR 820.30(g)", "21 CFR 820.30(h)", "21 CFR 820.30(i)" ] }, { "company": "Beta Bionics, Inc.", "letter_id": "beta-bionics-inc-717927", "date": "2026-01-28", "device": "", "risk_score": 95, "deficiency_count": 1, "top_clauses": [ "21 CFR 820.100(a)" ] }, { "company": "Unomedical Device S.A. de C.V.", "letter_id": "unomedical-device-sa-de-cv-719428", "date": "2026-01-08", "device": "", "risk_score": 95, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.198(c)", "21 CFR 820.100(a)" ] }, { "company": "Envoy Medical, Inc.", "letter_id": "envoy-medical-718762", "date": "2025-11-11", "device": "Esteem II Fully Implantable Hearing System (Class III)", "risk_score": 95, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.30(g)" ] }, { "company": "LifeVac, LLC", "letter_id": "lifevac-llc-713455", "date": "2025-09-18", "device": "", "risk_score": 95, "deficiency_count": 3, "top_clauses": [ "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 515(a) of the FD&C Act, 21 U.S.C. \u00a7 360e(a)", "Section 513(f)(1) of the FD&C Act, 21 U.S.C. \u00a7 360c(f)(1)" ] }, { "company": "Spectra Therapy, LLC", "letter_id": "spectra-therapy-llc-698026", "date": "2025-07-22", "device": "", "risk_score": 95, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.30(a) through 820.30(j)", "21 CFR 820.90", "21 CFR 820.100", "21 CFR 820.198(e)", "21 CFR 820.50(a)(1)", "21 CFR 820.80(d)", "21 CFR 820.22", "21 CFR 820.20(c)", "21 CFR 820.40" ] }, { "company": "Mectronic Medicale S.R.L.", "letter_id": "mectronic-medicale-srl-707997", "date": "2025-06-27", "device": "", "risk_score": 95, "deficiency_count": 11, "top_clauses": [ "21 CFR 820.30(j)", "21 CFR 820.75(a)", "21 CFR 820.90", "21 CFR 820.80", "21 CFR 820.198(a)", "21 CFR 820.200", "21 CFR 820.25(b)", "21 CFR 820.184", "21 CFR 820.22", "21 CFR 803.17", "21 U.S.C. \u00a7 351(f)(1)(B) / 21 U.S.C. \u00a7 360(k)" ] }, { "company": "Insightra Medical Inc.", "letter_id": "insightra-medical-inc-706921", "date": "2025-06-03", "device": "Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Descri", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(A) / Section 501(f)(1)(A) of the Act; 21 CFR 807.81(a)(3)(ii)", "21 U.S.C. \u00a7 351(f)(1)(A) / Section 501(f)(1)(A); 21 U.S.C. \u00a7 360e(b) / Section 515(b)", "21 CFR 803.17", "21 CFR 803.17(a)(1)", "21 CFR 803.50(a)(1); 21 U.S.C. \u00a7 352(t)(2)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the Act" ] }, { "company": "ICU Medical", "letter_id": "icu-medical-702535", "date": "2025-04-04", "device": "APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets an", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 CFR 807.81(a)(3)(i)", "21 U.S.C. \u00a7 351(f)(1)(B) (Section 501(f)(1)(B) of the FD&C Act)", "21 U.S.C. \u00a7 352(o) (Section 502(o) of the FD&C Act) / 21 U.S.C. \u00a7 360(k) (Section 510(k))", "21 CFR 807.81(a)(3)(i) - Internal Procedure Non-Compliance", "21 CFR 806 / 21 CFR 807.81(a)(3)(i) - Recall Remediation Without Regulatory Submission" ] }, { "company": "DRG Instruments GmbH", "letter_id": "drg-instruments-gmbh-700918", "date": "2025-03-31", "device": "DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic", "risk_score": 95, "deficiency_count": 8, "top_clauses": [ "21 CFR 807.81(a)(3)(i) / Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k)", "Section 501(f)(1)(B) of the Act, 21 U.S.C. \u00a7 351(f)(1)(B) / Section 515(a), 21 U.S.C. \u00a7 360e(a)", "Section 502(o) of the Act, 21 U.S.C. \u00a7 352(o) / 21 CFR 807.81(a)(3)", "21 CFR 809.10(c)(2) / Section 501(f)(1)(B) and 502(o) of the Act", "21 CFR 807.81(a)(1) or 807.81(a)(3)", "Section 510(k) of the Act / 21 CFR 807.81", "Section 510(k) of the Act / 21 CFR Part 807", "21 CFR 807.81(a)(3)(i) - Repeat Violation from 2017 Warning Letter" ] }, { "company": "Rex Implants Inc.", "letter_id": "rex-implants-inc-676429", "date": "2025-03-12", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the FD&C Act) / 21 U.S.C. \u00a7 351(f)(1)(B) (Section 501(f)(1)(B))", "21 U.S.C. \u00a7 360(k) (Section 510(k)) / 21 U.S.C. \u00a7 352(o) (Section 502(o))", "21 U.S.C. \u00a7 360e(a) / 21 U.S.C. \u00a7 351(f)(1)(B) / 21 U.S.C. \u00a7 360(k)", "21 CFR 820.30(i) (Design Changes) / FDA Guidance 'Deciding When to Submit a 510(k) for a Change to an Existing Device'", "21 U.S.C. \u00a7 352(o) (Section 502(o)) / 21 CFR 807.81" ] }, { "company": "Next Science LLC", "letter_id": "next-science-llc-698114", "date": "2025-02-21", "device": "", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 CFR 807.81(b) - Premarket Notification Requirements" ] }, { "company": "Exer Labs, Inc.", "letter_id": "exer-labs-inc-699218", "date": "2025-02-10", "device": "", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.50", "21 CFR 820.20(c)", "21 CFR 820.22", "21 CFR 820.25(b)" ] }, { "company": "Q\u2019Apel Medical, Inc.", "letter_id": "qapel-medical-inc-699244", "date": "2025-02-05", "device": "", "risk_score": 95, "deficiency_count": 2, "top_clauses": [ "21 CFR 807.81(a)(3) / Section 510(k)", "21 CFR 820.30(c)" ] }, { "company": "Robbins Instruments, LLC", "letter_id": "robbins-687984", "date": "2025-01-21", "device": "Needleless Injector (Class II)", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.75(c)", "21 CFR 820.30(i)", "21 CFR 820.198(c)", "21 CFR 820.184", "21 CFR 820.80(e)", "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k); Section 501(f)(1)(B), 21 U.S.C. \u00a7 351(f)(1)(B)" ] }, { "company": "Hologic, Inc.", "letter_id": "hologic-698214", "date": "2024-12-18", "device": "BioZorb Marker (Class III)", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.30(c)", "21 CFR 820.30(f)", "21 CFR 820.30(g)", "21 CFR 820.30(h)", "21 CFR 820.100(a)(1)", "21 CFR 803.50(a)(1)" ] }, { "company": "Anne\u2019s Daye Ltd dba Tampon Innovations", "letter_id": "annes-daye-ltd-dba-tampon-innovations-696362", "date": "2024-12-17", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the Act) / 21 U.S.C. \u00a7 351(f)(1)(B) (Section 501(f)(1)(B) of the Act)", "21 U.S.C. \u00a7 352(o) (Section 502(o) of the Act) / 21 U.S.C. \u00a7 360(k) (Section 510(k) of the Act) / 21 CFR 807.81(a)(3)(i) and (ii)", "21 U.S.C. \u00a7 352(o) (Section 502(o) of the Act) / 21 U.S.C. \u00a7 360(k) (Section 510(k) of the Act)", "21 CFR 820.198(a)" ] }, { "company": "Sanitation & Environmental Technology Institute dba SDWH", "letter_id": "sanitation-environmental-technology-institute-dba-sdwh-687970", "date": "2024-09-10", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 CFR 58.33(a)", "21 CFR 58.33(b)", "21 CFR 58.33(c)", "21 CFR 58.33(e)", "21 CFR 58.33(f)", "21 CFR 58.120" ] }, { "company": "LEEL Tech", "letter_id": "leel-tech-677297", "date": "2024-08-07", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 CFR 807.81(a) / 21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 331 / Section 301 of the FD&C Act", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 U.S.C. \u00a7 321(h) / Section 201(h) of the FD&C Act" ] }, { "company": "Jiangsu Caina Medical Co., Ltd", "letter_id": "jiangsu-caina-medical-co-ltd-687033", "date": "2024-07-18", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)(1)", "21 CFR 820.100(a)(2)", "21 CFR 820.30(g)", "21 CFR 803.50(a)(2)" ] }, { "company": "Criticare Technologies, Inc.", "letter_id": "criticare-technologies-inc-686915", "date": "2024-07-12", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(a)", "21 CFR 820.50", "21 CFR 820.90(a)" ] }, { "company": "AG Essence, Inc.", "letter_id": "ag-essence-inc-678344", "date": "2024-06-14", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360(k) / Section 510(k) of the Act", "21 CFR 801.20(a) / 21 CFR Part 801 Subpart B / 21 CFR Part 830", "21 CFR 830.300(a) / 21 CFR 830.320(b) / 21 CFR Part 830 Subpart E", "21 U.S.C. \u00a7 360 / Section 510 of the Act / 21 CFR Part 807", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the Act" ] }, { "company": "Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs", "letter_id": "pinnacle-labs-of-tennessee-llc-dba-pinnacle-biolabs-676367", "date": "2024-04-17", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 CFR 807.81", "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.3(o) / 21 CFR Part 820 (General QSR Compliance)", "21 CFR 803 (MDR Reporting)" ] }, { "company": "Bioptimal International", "letter_id": "bioptimal-international-678281", "date": "2024-04-03", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 CFR 807.81(a)(3)(i)", "21 CFR 820.198(a) and (d)", "21 CFR 820.100(a)", "21 CFR 820.30(g)", "21 CFR 820.75" ] }, { "company": "Agena Bioscience, Inc.", "letter_id": "agena-bioscience-inc-665159", "date": "2024-03-21", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2013 Premarket Approval (PMA) / 510(k) Requirements (21 CFR 807.81)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act \u2013 Misbranding for failure to submit 510(k) notification (21 CFR 807.81(a)(1) and (a)(3))", "21 CFR 809.10(c) \u2013 Labeling for Research Use Only (RUO) devices", "21 CFR 806.10 \u2013 Reports of Corrections and Removals", "21 U.S.C. \u00a7 352(t)(2) / Section 502(t)(2) of the FD&C Act \u2013 Failure to furnish required information under Section 519 (21 CFR Part 806)" ] }, { "company": "Soulaire Corporation", "letter_id": "soulaire-corporation-675069", "date": "2024-01-29", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 CFR 807.81(a)(3)(ii)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR 807.81(b)", "21 CFR 801.87(a)(3)(ii) / 21 CFR 870.5225", "21 CFR 801.109 / K202108 Cleared Labeling Conditions" ] }, { "company": "Ostar Beauty Sci-Tech Co Ltd.", "letter_id": "ostar-beauty-sci-tech-co-ltd-667871", "date": "2023-12-04", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act (Premarket Approval)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act (Premarket Notification)", "21 U.S.C. \u00a7 360 / 21 CFR Part 807 (Establishment Registration and Device Listing)", "21 CFR Part 820 (Quality System Regulation) / 21 U.S.C. \u00a7 360j", "21 CFR 801 / 21 U.S.C. \u00a7 352 (Labeling and Misbranding)" ] }, { "company": "Fresenius Medical Care AG & Co. KGaA", "letter_id": "fresenius-medical-care-ag-co-kgaa-666791", "date": "2023-12-04", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.100(b)", "21 CFR 820.30(g)", "21 CFR 806.10(b)" ] }, { "company": "Neurotris, Inc. dba A1 Engineering", "letter_id": "neurotris-inc-dba-a1-engineering-659244", "date": "2023-10-27", "device": "", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the FD&C Act]", "21 U.S.C. \u00a7 352(o) [Section 502(o) of the FD&C Act] / 21 CFR 807.81(a)", "21 CFR 807.81(a) / 21 CFR 890.5850", "21 CFR 807.81(a) / 21 U.S.C. \u00a7 352(o)", "21 CFR 801 (Labeling) / 21 U.S.C. \u00a7 352", "21 CFR 890.5850 / 21 U.S.C. \u00a7 360e(a)" ] }, { "company": "WAVi Co.", "letter_id": "wavi-co-658549", "date": "2023-10-20", "device": "WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporat", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k) / Section 515(a) of the Act, 21 U.S.C. \u00a7 360e(a) / Section 520(g) of the Act, 21 U.S.C. \u00a7 360j(g)", "21 CFR 820.30(g)", "21 CFR 820.75(a)", "21 CFR 820.184(d)", "21 CFR 820.181", "21 CFR 820.22" ] }, { "company": "iRhythm Technologies, Inc.", "letter_id": "irhythm-technologies-inc-643474", "date": "2023-05-25", "device": "Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act; 21 CFR 807.81(a)(3)", "21 U.S.C. \u00a7 352(f)(1) / Section 502(f)(1) of the FD&C Act; 21 CFR 801.109", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 U.S.C. \u00a7 360(k)" ] }, { "company": "Steiner Biotechnology, LLC", "letter_id": "steiner-biotechnology-llc-651802", "date": "2023-05-19", "device": "", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.30(f)", "21 CFR 820.30(g)", "21 CFR 820.75(a)", "21 CFR 820.50", "21 CFR 820.80(a)", "21 CFR 820.72" ] }, { "company": "Sea-Long Medical Systems, LLC", "letter_id": "sea-long-medical-systems-llc-647320", "date": "2023-04-04", "device": "", "risk_score": 95, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.75(a)", "21 CFR 820.30(i)", "21 CFR 820.100(a)", "21 CFR 820.90(a)", "21 CFR 820.80(d)", "21 CFR 820.80(b)", "21 CFR 820.181", "21 CFR 820.184" ] }, { "company": "RightEye, LLC", "letter_id": "righteye-llc-643192", "date": "2022-12-20", "device": "", "risk_score": 95, "deficiency_count": 7, "top_clauses": [ "21 CFR 510(k) / 807.81(a)(3)(ii) / Section 501(f)(1)(B)", "21 CFR 830.300(a) / 830.320(b) / Section 502(t)(2)", "21 CFR 820.30", "21 CFR 820.30(j)", "21 CFR 820.198(a)", "21 CFR 820.90", "21 CFR 820.50" ] }, { "company": "Abbott Point of Care Canada Limited", "letter_id": "abbott-point-of-care-canada-limited-640946", "date": "2022-11-08", "device": "Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or pl", "risk_score": 95, "deficiency_count": 3, "top_clauses": [ "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k) and 21 CFR 807.81(a)(3)", "21 CFR 820.30(i)", "21 CFR 820.180" ] }, { "company": "Empowered Diagnostics LLC", "letter_id": "empowered-diagnostics-llc-638164", "date": "2022-10-06", "device": "CovClear COVID-19 Rapid Antigen Test, ATG 900-031", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.80(d)", "21 CFR 820.50" ] }, { "company": "NeuroField, Inc.", "letter_id": "neurofield-inc-621767", "date": "2022-02-28", "device": "", "risk_score": 95, "deficiency_count": 8, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act - Adulteration", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act - Misbranding / 21 CFR 807.81 (510(k) requirement)", "21 CFR 882.5050 / 21 CFR 882.1400 - Device Classification", "21 CFR 820.30 - Design Controls", "21 CFR 820.198 / 21 CFR 801 - Labeling", "21 CFR 820.20 - Management Responsibility", "21 CFR 820.184 - Device History Record", "21 CFR 820.250 - Statistical Techniques / 21 CFR 820.30(g) - Design Validation" ] }, { "company": "CardioQuip, LLC", "letter_id": "cardioquip-llc-621738", "date": "2022-02-11", "device": "CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103", "risk_score": 95, "deficiency_count": 8, "top_clauses": [ "21 CFR 807.81(a)(3) / Section 510(k)", "21 CFR 820.30(g) and 820.30(i)", "21 CFR 820.30(g)", "21 CFR 820.30(c)", "21 CFR 820.75(a)", "21 CFR 820.100(a)" ] }, { "company": "DermaCare Biosciences, LTD.", "letter_id": "dermacare-biosciences-ltd-617910", "date": "2021-12-01", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 Premarket Notification", "21 U.S.C. \u00a7 331(a) and 331(k) / Sections 301(a) and 301(k) of the FD&C Act \u2014 Prohibited Acts", "21 CFR 801 / Section 502 of the FD&C Act \u2014 Labeling and Promotional Claims", "21 CFR 1.21 / FDA Logo Misuse \u2014 Federal Law" ] }, { "company": "DSAART, LLC. dba Alpha Aesthetics", "letter_id": "dsaart-llc-dba-alpha-aesthetics-618157", "date": "2021-11-24", "device": "Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: ", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.90(a)", "21 CFR 820.30(g)", "21 CFR 803.50(a)(1)" ] }, { "company": "Owlet Baby Care, Inc.", "letter_id": "owlet-baby-care-inc-616354", "date": "2021-10-05", "device": "", "risk_score": 95, "deficiency_count": 3, "top_clauses": [ "Section 510(k) of the FD&C Act, 21 U.S.C. \u00a7 360(k) / Section 515(a), 21 U.S.C. \u00a7 360e(a)", "Section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 301(a) of the FD&C Act, 21 U.S.C. \u00a7 331(a)" ] }, { "company": "Lepu Medical Technology -Beijing- Co., Ltd.", "letter_id": "lepu-medical-technology-beijing-co-ltd-614908", "date": "2021-07-29", "device": "Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and veni", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) - Section 515(a) of the FD&C Act (Premarket Approval)", "21 U.S.C. \u00a7 360(k) - Section 510(k) of the FD&C Act (Premarket Notification)", "21 U.S.C. \u00a7 331(a) and 331(k) - Sections 301(a) and 301(k) of the FD&C Act (Prohibited Acts)", "21 CFR 807 - Establishment Registration and Device Listing" ] }, { "company": "Vivera Pharmaceuticals, Inc.", "letter_id": "vivera-pharmaceuticals-inc-614382", "date": "2021-07-26", "device": "", "risk_score": 95, "deficiency_count": 8, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Premarket Approval)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding - Failure to file 510(k))", "21 U.S.C. \u00a7 331(a) - Section 301(a) of the FD&C Act (Prohibited Acts - Interstate Commerce)", "21 U.S.C. \u00a7 331(k) - Section 301(k) of the FD&C Act (Prohibited Acts - Misbranding while held for sale)", "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 Premarket Notification", "21 U.S.C. \u00a7 331(a) and 331(k) / Sections 301(a) and 301(k) of the FD&C Act \u2014 Prohibited Acts", "21 CFR 809 \u2014 In Vitro Diagnostic Products (Labeling) / 21 U.S.C. \u00a7 352(o)" ] }, { "company": "Aquavit Pharmaceuticals, Inc", "letter_id": "aquavit-pharmaceuticals-inc-607150", "date": "2021-06-17", "device": "", "risk_score": 95, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act (PMA requirement)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act (Premarket Notification)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act (Misbranding)", "21 CFR 878.4430 (Classification for microneedling devices)", "21 CFR Part 4 / 21 CFR 3.2(e) (Combination Product Requirements)" ] }, { "company": "Amplicon Land, LLC", "letter_id": "amplicon-land-llc-607975", "date": "2021-06-07", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the FD&C Act) \u2014 Premarket Approval", "21 U.S.C. \u00a7 360(k) (Section 510(k) of the FD&C Act) \u2014 Premarket Notification", "21 U.S.C. \u00a7 331(a) and 331(k) (Sections 301(a) and 301(k) of the FD&C Act) \u2014 Prohibited Acts", "21 CFR 807 \u2014 Establishment Registration and Device Listing (implied)", "21 CFR 820 (Quality System Regulation) \u2014 General (implied)" ] }, { "company": "DeChoker LLC", "letter_id": "dechoker-llc-614629", "date": "2021-05-10", "device": "", "risk_score": 95, "deficiency_count": 8, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.30(a)", "21 CFR 820.30(c)", "21 CFR 820.30(f)", "21 CFR 820.30(g)", "21 CFR 820.100(a)", "21 CFR 820.80(a)", "21 CFR 820.90(b)(2)" ] }, { "company": "Professional World Store", "letter_id": "professional-world-store-612406", "date": "2021-04-27", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Requirements)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act (Premarket Notification)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act (Misbranding - False or Misleading Labeling)", "FDA Logo Policy / 21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act", "21 CFR Part 807 (Establishment Registration and Device Listing)" ] }, { "company": "BMHshop", "letter_id": "bmhshop-612991", "date": "2021-04-26", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR Part 807 Subpart E", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act", "21 CFR Part 807 / 21 U.S.C. \u00a7 360 / Section 510 of the FD&C Act" ] }, { "company": "Sethi Laboratories", "letter_id": "sethi-laboratories-611628", "date": "2021-04-06", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding - failure to file 510(k))", "21 U.S.C. \u00a7 352(a) - Section 502(a) of the FD&C Act (Misbranding - false or misleading labeling)", "21 U.S.C. \u00a7 331(a) and 331(k) - Sections 301(a) and 301(k) of the FD&C Act (Prohibited acts)" ] }, { "company": "Block Scientific", "letter_id": "block-scientific-609533", "date": "2021-03-18", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the FD&C Act) / 21 U.S.C. \u00a7 360(k) (Section 510(k) of the FD&C Act)", "21 U.S.C. \u00a7 352(o) (Section 502(o) of the FD&C Act) / 21 CFR Part 807", "21 U.S.C. \u00a7 331(a) and 331(k) (Sections 301(a) and 301(k) of the FD&C Act)", "21 CFR 820.30 / 21 CFR 820.184" ] }, { "company": "maskshell.com", "letter_id": "maskshellcom-611829", "date": "2021-03-11", "device": "", "risk_score": 95, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Requirements)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 CFR 807 Subpart E (510(k) Premarket Notification)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 CFR 807 Subpart B and C (Establishment Registration and Device Listing)" ] }, { "company": "Orvic dba Webstore-USA", "letter_id": "orvic-dba-webstore-usa-610208", "date": "2021-02-26", "device": "", "risk_score": 95, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Approval - 21 CFR Part 814)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act (21 CFR Part 807 - Premarket Notification / 510(k))", "21 U.S.C. \u00a7 331(a) and 331(k) / Sections 301(a) and 301(k) of the FD&C Act", "21 CFR Part 809 (In Vitro Diagnostic Products for Human Use) / FDA COVID-19 Test Policy Guidance" ] }, { "company": "Contec Medical Systems Co., Ltd.", "letter_id": "contec-medical-systems-co-ltd-717941", "date": "2025-10-02", "device": "CMS8000 Patient Monitor", "risk_score": 93, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(g)", "21 CFR 820.198(a)", "21 CFR 820.180", "21 CFR 806.10(c)(12)" ] }, { "company": "Medline Industries, LP", "letter_id": "medline-industries-lp-723866", "date": "2026-03-25", "device": "Sterile Procedural Trays, labeled as the following: a.\tBREAST AUGMENTATION b.\tBREAST REDUCTION CDS c.\tCUH ABDOMINOPLASTY CDS d.\tACH PLASTICS BREAST-LF e.\tNE BREAST RECON CDS f.\tPLASTIC SURGER", "risk_score": 92, "deficiency_count": 10, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.70(g)(1)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act; 21 CFR 807.81(b)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 U.S.C. \u00a7 360(k)", "21 CFR 820.50 (Purchasing Controls)", "21 CFR 820.30(g) (Design Validation) / 21 CFR 820.30(i) (Design Changes)", "21 CFR 820.198 (Complaint Files)", "21 CFR 820.90 (Nonconforming Product)", "21 CFR 820.184 / 21 CFR 820.180 (Device History Record / General Requirements for Records)" ] }, { "company": "IsoTis OrthoBiologics, Inc.", "letter_id": "isotis-orthobiologics-inc-723370", "date": "2026-02-24", "device": "OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.75(c)", "21 CFR 820.30(g)" ] }, { "company": "Meridian Bioscience, Inc", "letter_id": "meridian-bioscience-inc-720826", "date": "2025-12-22", "device": "Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(c)", "21 CFR 820.30(g)", "21 CFR 820.75(a)", "21 CFR 820.80(b)" ] }, { "company": "Exactech, Inc. dba Advita Ortho", "letter_id": "exactech-inc-dba-advita-ortho-720250", "date": "2025-12-19", "device": "Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Num", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.70(a)", "21 CFR 820.100(a)" ] }, { "company": "Hong Qiangxing Shenzhen Electronics Limited", "letter_id": "hong-qiangxing-shenzhen-electronics-limited-718112", "date": "2025-10-28", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.30(i)", "21 CFR 820.30(f)", "21 CFR 820.30(j)", "21 CFR 820.90(a)" ] }, { "company": "Avertix Medical, Inc.", "letter_id": "avertix-medical-inc-711080", "date": "2025-09-03", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.198(a)(1)", "21 CFR 820.198(c)", "21 CFR 820.90(a)", "21 CFR 820.30(g)" ] }, { "company": "The Richline Group, Inc.", "letter_id": "the-richline-group-inc-712818", "date": "2025-08-25", "device": "", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.75(a)", "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k)" ] }, { "company": "Uscom Kft", "letter_id": "uscom-kft-708491", "date": "2025-07-30", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "Section 501(f)(1)(B), 510(k) - 21 U.S.C. \u00a7 351(f)(1)(B)", "21 CFR 820.30(g)", "21 CFR 820.100(a)", "21 CFR 820.75(a)", "21 CFR 820.90(a)", "21 CFR 820.198(a), 820.198(b)" ] }, { "company": "Les Encres LLC", "letter_id": "les-encres-llc-709263", "date": "2025-07-30", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.198", "21 CFR 820.100(a) and (b)", "21 CFR 820.50", "21 CFR 820.25(b)", "21 CFR 803.17", "21 U.S.C. \u00a7 351(f)(1)(B) / 21 U.S.C. \u00a7 352(o) / 21 CFR 807.81(a)(3)(ii)" ] }, { "company": "WHOOP, Inc.", "letter_id": "whoop-inc-709755", "date": "2025-07-14", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act (PMA requirement)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 U.S.C. \u00a7 360(k) / Section 510(k); 21 CFR 807.81(b)", "21 U.S.C. \u00a7 321(h) / Section 201(h) of the FD&C Act; 21 CFR 801.4", "21 CFR 870.1130 (Blood pressure measurement device classification); General Wellness Guidance" ] }, { "company": "Aju Pharm Co., Ltd.", "letter_id": "aju-pharm-co-ltd-704823", "date": "2025-05-21", "device": "AlternatiV+ Screw-In Anchor", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.50", "21 CFR 820.70(a)", "21 CFR 803.17" ] }, { "company": "Kabe Labortechnik GmbH", "letter_id": "kabe-labortechnik-gmbh-704563", "date": "2025-05-09", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.70(g)", "21 CFR 820.30(a)", "21 CFR 820.100(a)" ] }, { "company": "NeuroSync, Inc.", "letter_id": "neurosync-inc-705489", "date": "2025-05-09", "device": "NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field cas", "risk_score": 92, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.30(f)", "21 CFR 820.30(i)", "21 CFR 820.30(c)", "21 CFR 820.30(g)", "21 CFR 820.100(a)(5)", "21 CFR 820.50", "21 CFR 820.80(a)", "21 CFR 806.10", "21 CFR 801.20(a) / Section 502(c) of the Act" ] }, { "company": "Noah Medical Corporation", "letter_id": "noah-medical-corporation-702414", "date": "2025-04-09", "device": "Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization ", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.30", "21 CFR 820.90(a)" ] }, { "company": "EpiCare Acquisitions, LLC", "letter_id": "epicare-acquisitions-llc-702493", "date": "2025-03-21", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.198(a)(1)", "21 CFR 820.198(b)", "21 CFR 820.198(d)", "21 CFR 820.100(a)(1)", "21 CFR 820.100(a)(5)", "21 CFR 820.184" ] }, { "company": "Dexcom, Inc.", "letter_id": "dexcom-inc-700835", "date": "2025-03-04", "device": "Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CG", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.75(b)", "21 CFR 820.75(a)", "21 CFR 820.30(c)", "21 CFR 820.30(i)" ] }, { "company": "Red Oak Instruments, LLC", "letter_id": "red-oak-instruments-llc-692368", "date": "2025-02-21", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the Act; 21 CFR 807.81(a)(3)(ii)", "21 CFR 803.17(a)(1)", "21 CFR 803.17(a)(2)", "21 CFR 803.17(a)(3)", "21 CFR 803.17(b); 21 CFR 803.18(b)(1)(i)", "21 CFR Part 803 (eMDR requirement)" ] }, { "company": "Integra LifeSciences Corporation", "letter_id": "integra-lifesciences-corporation-698850", "date": "2024-12-19", "device": "Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized bl", "risk_score": 92, "deficiency_count": 8, "top_clauses": [ "21 CFR 820.90(a)", "21 CFR 820.80(a)", "21 CFR 820.80(d)", "21 CFR 820.100(a)", "21 CFR 820.100(a)(1)", "21 CFR 820.75(a)", "21 CFR 820.150(a)" ] }, { "company": "Phillips Precision, Inc.", "letter_id": "phillips-precision-inc-697119", "date": "2024-12-09", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.75(a)" ] }, { "company": "Rontis Hellas S.A.", "letter_id": "rontis-hellas-sa-695160", "date": "2024-10-28", "device": "", "risk_score": 92, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 803.17" ] }, { "company": "Rolence Ent. Inc.", "letter_id": "rolence-ent-inc-695010", "date": "2024-10-18", "device": "", "risk_score": 92, "deficiency_count": 8, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.100(a)", "21 CFR 820.198(a)", "21 CFR 820.86", "21 CFR 820.70(i)", "21 CFR 820.120", "21 CFR 820.184", "21 CFR 803.17" ] }, { "company": "Mid-Link Testing Company, Ltd", "letter_id": "mid-link-testing-company-ltd-687111", "date": "2024-09-10", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 58.33(b)", "21 CFR 58.33(c)", "21 CFR 58.130(a)" ] }, { "company": "Shenzhen Moyeah Intelligent Life Technology Co.", "letter_id": "shenzhen-moyeah-intelligent-life-technology-co-677092", "date": "2024-08-08", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR 807.81(a)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 CFR 807.81(a) / 21 CFR Part 820 (Quality System Regulation)" ] }, { "company": "Natures Pillows, Inc. and Top Dog Direct, LLC", "letter_id": "natures-pillows-inc-and-top-dog-direct-llc-676849", "date": "2024-08-07", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR 807.81(a)(1)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 CFR 880.6890 - Misapplication of Exemption" ] }, { "company": "Adventure Innovations LLC", "letter_id": "adventure-innovations-llc-676842", "date": "2024-08-07", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 CFR 807.81(a)(1) / 21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 U.S.C. \u00a7 321(h) / Section 201(h) of the FD&C Act" ] }, { "company": "Jiangsu Shenli Medical Production Co., Ltd.", "letter_id": "jiangsu-shenli-medical-production-co-ltd-687035", "date": "2024-07-18", "device": "Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(a)(1)", "21 CFR 820.181", "21 U.S.C. \u00a7 360(k) / 21 CFR 807.81(a)(3)(i)-(ii)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 CFR 820.198 / Post-Market Surveillance", "21 CFR 820.30(b) / Design and Development Planning" ] }, { "company": "Globus Medical, Inc.", "letter_id": "globus-medical-inc-685606", "date": "2024-07-15", "device": "ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)(1)", "21 CFR 820.198(c)", "21 CFR 803.50(a)(1)", "21 CFR 803.50(a)(2)" ] }, { "company": "Baylab USA, LLC", "letter_id": "baylab-usa-llc-679001", "date": "2024-06-27", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.50(a)", "21 CFR 820.22", "21 CFR 820.198(a)", "21 CFR 807.81(a)(3)(i)-(ii) / Section 510(k)", "Section 501(f)(1)(B) / 21 U.S.C. \u00a7 351(f)(1)(B)", "21 CFR 801.20(a) / Section 502(c)" ] }, { "company": "AMCO International Manufacturing & Design, Inc.", "letter_id": "amco-international-manufacturing-design-inc-681557", "date": "2024-06-25", "device": "", "risk_score": 92, "deficiency_count": 1, "top_clauses": [ "Section 501(f)(1)(A) of the FD&C Act, 21 U.S.C. \u00a7 351(f)(1)(A); Section 515(b) of the FD&C Act, 21 U.S.C. \u00a7 360e(b); 21 CFR 870.5310" ] }, { "company": "Cue Health, Inc.", "letter_id": "cue-health-inc-675673", "date": "2024-05-09", "device": "Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)", "risk_score": 92, "deficiency_count": 2, "top_clauses": [ "EUA Condition K (EUA200248) / Condition L (EUA210180) \u2014 related to 21 CFR 820.30 (Design Controls) and 21 CFR 820.70 (Production and Process Controls)", "EUA Condition M (EUA200248) / Condition N (EUA210180) \u2014 related to 21 CFR 820.80 (Receiving, In-Process, and Finished Device Acceptance) and 21 CFR 820.250 (Statistical Techniques)" ] }, { "company": "Cardinal Health", "letter_id": "cardinal-health-679404", "date": "2024-04-24", "device": "Monoject Syringes (Class II)", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k); 21 CFR 807.81(b)", "21 CFR 820.50", "21 CFR 820.50 (related to design change and intended use evaluation)" ] }, { "company": "Sol-Millennium Medical, Inc.", "letter_id": "sol-millennium-medical-inc-677524", "date": "2024-03-18", "device": "Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET,", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360(k) / 21 CFR 807.81(a)(3)(i)-(ii)", "21 U.S.C. \u00a7 351(f)(1)(B) / 21 U.S.C. \u00a7 360e(a)", "21 U.S.C. \u00a7 352(o) / 21 U.S.C. \u00a7 360(k)", "21 CFR 807.20(a) / 21 U.S.C. \u00a7 360 (Section 510)", "21 U.S.C. \u00a7 360 (Section 510) / 21 CFR 807.21-807.40", "21 CFR 807.40(a) / 21 U.S.C. \u00a7 360(j)(1)" ] }, { "company": "Trexo Robotics Holdings Inc.", "letter_id": "trexo-robotics-holdings-inc-673150", "date": "2024-02-07", "device": "Trexo Device", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.75(a)", "21 CFR 820.100(a)(1)", "21 CFR 820.198", "21 U.S.C. \u00a7 360e(a) / 21 U.S.C. \u00a7 360(k)" ] }, { "company": "Nobles Medical Technology II, Inc.", "letter_id": "nobles-medical-technology-ii-inc-673465", "date": "2024-01-26", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 812.40", "21 CFR 812.43(a) and (d)", "21 CFR 812.43(c)(4)(i)", "21 CFR 812.43(c)(5)", "21 CFR 812.40 (International Sites)" ] }, { "company": "Dr. Joel Kaplan Inc.", "letter_id": "dr-joel-kaplan-inc-667193", "date": "2024-01-08", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 CFR 807 Subpart E (Premarket Notification / 510(k))", "21 CFR 807 Subpart E (Premarket Notification / 510(k)) and 21 CFR 884.5970", "21 CFR 801 (Labeling) / FD&C Act Section 502", "21 CFR 807.20-807.41 (Device Registration and Listing)" ] }, { "company": "Fresenius Kabi AG", "letter_id": "fresenius-kabi-ag-671249", "date": "2024-01-04", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR \u00a7 820.100(a)", "21 CFR \u00a7 820.30(a)", "21 CFR \u00a7 820.30(g)", "21 CFR \u00a7 820.30(i)", "21 CFR \u00a7 803.50(a)(2)", "21 CFR \u00a7 803.17" ] }, { "company": "Terragene S.A.", "letter_id": "terragene-sa-667432", "date": "2023-11-01", "device": "ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.198(a)(b)", "21 CFR 803.17", "21 CFR 807.81(b) / Section 510(k) of the Act" ] }, { "company": "Acrostak Schweiz AG", "letter_id": "acrostak-schweiz-ag-668948", "date": "2023-10-31", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 807.81(a)(3) - Premarket Notification (510(k))", "21 CFR 820.75(b)(2) - Process Validation: Monitoring and Control of Process Parameters", "21 CFR 820.30(g) - Design Validation" ] }, { "company": "Spectrum Medical Ltd", "letter_id": "spectrum-medical-ltd-666543", "date": "2023-09-29", "device": "Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is int", "risk_score": 92, "deficiency_count": 8, "top_clauses": [ "21 CFR 807.81(a)(3)(ii)", "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the Act]", "21 U.S.C. \u00a7 352(o) [Section 502(o) of the Act]" ] }, { "company": "Abiomed Inc.", "letter_id": "abiomed-inc-663150", "date": "2023-09-19", "device": "Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Pack", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.100(a)(3)", "21 CFR 820.100(a)(4)", "Section 501(f)(1)(B) of the Act / 21 U.S.C. \u00a7 351(f)(1)(B)" ] }, { "company": "P.T. Sankei Medical Industries", "letter_id": "pt-sankei-medical-industries-665754", "date": "2023-09-19", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 CFR 807.81(a)(3)(i)", "21 CFR 820.30(a)", "21 CFR 820.50", "21 CFR 820.184", "21 CFR 820.181", "21 CFR 820.198", "21 CFR 820.22" ] }, { "company": "BYD Precision Manufacture Co., Ltd", "letter_id": "byd-precision-manufacture-co-ltd-666250", "date": "2023-09-05", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.30", "21 CFR 820.75(a)", "21 CFR 820.181", "21 CFR 820.198(a)", "21 CFR 803.17" ] }, { "company": "King Systems Corp. dba Ambu, Inc.", "letter_id": "king-systems-corp-dba-ambu-inc-661617", "date": "2023-08-16", "device": "AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act - Premarket Approval (PMA)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR 807.81(b)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act - Labeling and Promotional Claims" ] }, { "company": "Outset Medical, Inc.", "letter_id": "outset-medical-inc-656485", "date": "2023-07-05", "device": "Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001", "risk_score": 92, "deficiency_count": 2, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act; 21 CFR 807.81(a)(3)(i)" ] }, { "company": "Olympus Medical Systems Corp.", "letter_id": "olympus-medical-systems-corp-654013", "date": "2023-03-15", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.100(a)(1)", "21 CFR 820.75(c)", "21 CFR 820.198", "21 CFR 803.17(a)", "21 CFR 820.100(a)(1) / 21 CFR 820.30(g)", "21 CFR 820.90" ] }, { "company": "Medivance Instruments Ltd.", "letter_id": "medivance-instruments-ltd-647562", "date": "2023-02-13", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 807.81(a)(3) / Section 510(k)", "21 CFR 820.30(i)", "21 CFR 820.100(a)", "21 CFR 820.198(b)", "21 CFR 820.184", "21 CFR Part 803 / Section 519 of the Act" ] }, { "company": "Getsch+Hiller Medizintechnik GmbH", "letter_id": "getschhiller-medizintechnik-gmbh-644680", "date": "2022-12-27", "device": "", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.30(j)", "21 CFR 820.80(b)", "21 U.S.C. \u00a7 360(k) / 21 CFR 807.81(a)(3)" ] }, { "company": "JAS Diagnostics/Drew Scientific, Inc.", "letter_id": "jas-diagnosticsdrew-scientific-inc-634208", "date": "2022-08-16", "device": "Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.75(a)" ] }, { "company": "Flawless Beauty and Skin", "letter_id": "flawless-beauty-and-skin-630567", "date": "2022-08-05", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act; 21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 CFR 807.20(a)(5); 21 U.S.C. \u00a7 360 / Section 510 of the FD&C Act; 21 U.S.C. \u00a7 360(p) / Section 510(p) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 CFR 807.3(g); 21 CFR 807.20(a)(5)" ] }, { "company": "Zyno Medical LLC", "letter_id": "zyno-medical-llc-629844", "date": "2022-07-12", "device": "Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(i)", "21 CFR 820.198(c)", "21 CFR 803 (Medical Device Reporting)" ] }, { "company": "W.H.P.M, Inc.", "letter_id": "whpm-inc-629146", "date": "2022-06-30", "device": "", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.60", "21 CFR 820.186", "Section 501(f)(1)(B) of the FD&C Act / 21 U.S.C. \u00a7 351(f)(1)(B)" ] }, { "company": "InfuTronix LLC", "letter_id": "infutronix-llc-631050", "date": "2022-06-16", "device": "Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)(1)", "21 CFR 820.198(a)", "21 CFR 820.198(c)", "Section 502(t)(2) of the Act, 21 U.S.C. \u00a7 352(t)(2) / 21 CFR Part 803 (MDR)" ] }, { "company": "Skin Sheek", "letter_id": "skin-sheek-612682", "date": "2022-01-28", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act (PMA requirement)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act", "21 U.S.C. \u00a7 352 / Section 502 of the FD&C Act - False and Misleading Claims" ] }, { "company": "Wickimed Medical Equipment Manufacturing Co., Ltd.", "letter_id": "wickimed-medical-equipment-manufacturing-co-ltd-623042", "date": "2022-01-07", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.75(a)", "21 CFR 820.30(a)", "21 CFR 820.86", "21 CFR 820.40", "21 CFR 820.184" ] }, { "company": "Unimicro Medical Systems-Shenzhen Co., Ltd.", "letter_id": "unimicro-medical-systems-shenzhen-co-ltd-624560", "date": "2022-01-06", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.90(a)", "21 CFR 820.30(a)", "21 CFR 820.75(b)", "21 CFR 820.100(a)", "21 CFR 820.72(a)", "21 CFR 820.80(c)" ] }, { "company": "Sunstar Americas, Inc.", "letter_id": "sunstar-americas-inc-614058", "date": "2021-12-21", "device": "SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 CFR 211.100(a) and (b)", "21 CFR 211.192", "21 CFR 211.160(b)" ] }, { "company": "Induction Therapies, LLC", "letter_id": "induction-therapies-llc-616487", "date": "2021-11-23", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act", "21 CFR 801 - Labeling" ] }, { "company": "Global Medical Production Co Ltd", "letter_id": "global-medical-production-co-ltd-620544", "date": "2021-11-16", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.90(a)", "21 CFR 820.75(a)", "21 CFR 820.70(g)(1)", "21 CFR 820.86" ] }, { "company": "Smiths Medical ASD Inc.", "letter_id": "smiths-medical-asd-inc-617147", "date": "2021-10-01", "device": "PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/IN", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 CFR 803.50(a)(2)", "21 CFR 803.17", "21 CFR 806.10", "21 CFR 820.30(g)", "21 CFR 820.100" ] }, { "company": "Databazaar.com", "letter_id": "databazaarcom-617199", "date": "2021-09-03", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding - Failure to File 510(k))", "21 U.S.C. \u00a7 352(a) - Section 502(a) of the FD&C Act (Misbranding - False or Misleading Labeling)", "21 U.S.C. \u00a7 352(a) - Section 502(a) of the FD&C Act (Unauthorized Use of FDA Logo)", "21 CFR 807 - Establishment Registration and Device Listing" ] }, { "company": "Invisi Smart Technologies UK LTD", "letter_id": "invisi-smart-technologies-uk-ltd-614512", "date": "2021-08-24", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding - Failure to file 510(k))", "21 U.S.C. \u00a7 321(h) - Section 201(h) of the FD&C Act (Device Classification and Intended Use)", "21 CFR 807 - Establishment Registration and Device Listing", "21 CFR 820 (Quality System Regulation) - General" ] }, { "company": "Pairon Solutions LLC", "letter_id": "pairon-solutions-llc-616392", "date": "2021-08-09", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 U.S.C. \u00a7 360(k) / Section 510(k)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act" ] }, { "company": "Lexion Medical LLC", "letter_id": "lexion-medical-llc-613588", "date": "2021-07-26", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "Section 510(k) of the Act, 21 U.S.C. \u00a7 360(k); Section 501(f)(1)(B) of the Act, 21 U.S.C. \u00a7 351(f)(1)(B)", "Section 502(a) of the Act, 21 U.S.C. \u00a7 352(a); 21 CFR \u00a7 801.6", "Section 501(f)(1)(B) of the Act, 21 U.S.C. \u00a7 351(f)(1)(B); Section 502(o) of the Act, 21 U.S.C. \u00a7 352(o)", "Section 301(a) of the Act, 21 U.S.C. \u00a7 331(a); Section 301(k) of the Act, 21 U.S.C. \u00a7 331(k)" ] }, { "company": "Captain's Cloth LLC", "letter_id": "captains-cloth-llc-613965", "date": "2021-07-02", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2014 Premarket Approval (21 CFR Part 814) / 510(k) Clearance (21 CFR Part 807 Subpart E)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 21 CFR 807.81 (Premarket Notification)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act \u2014 21 CFR 801 (Labeling)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act \u2014 FDA Logo Policy", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act \u2014 21 CFR 801.4 (Misleading labeling claims)" ] }, { "company": "World Packaging Solutions, LLC", "letter_id": "world-packaging-solutions-llc-612824", "date": "2021-06-28", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Approval - 21 CFR Part 814 / 510(k) - 21 CFR Part 807 Subpart E)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 CFR 807 Subpart E (Premarket Notification - 510(k))", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / FDA Logo Policy", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act" ] }, { "company": "Zhejiang Xichen Medical Technology Co., Ltd.", "letter_id": "zhejiang-xichen-medical-technology-co-ltd-612946", "date": "2021-06-04", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the FD&C Act]", "21 U.S.C. \u00a7 352(o) [Section 502(o) of the FD&C Act]; 21 U.S.C. \u00a7 360(k) [Section 510(k)]", "21 U.S.C. \u00a7 352(a) [Section 502(a) of the FD&C Act]; 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) [Section 502(a) of the FD&C Act]", "21 CFR 807.20 (Establishment Registration and Device Listing)" ] }, { "company": "Nature\u2019s Distributing; Club Clean Inc/BuyMedicalMasksNow.com", "letter_id": "natures-distributing-club-clean-incbuymedicalmasksnowcom-613952", "date": "2021-05-28", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration - No PMA/IDE)", "21 U.S.C. \u00a7 360(k) - Section 510(k) of the FD&C Act (Premarket Notification)", "21 U.S.C. \u00a7 352(a) - Section 502(a) of the FD&C Act (Misbranding - False or Misleading Labeling)", "FDA Logo Policy / 21 U.S.C. \u00a7 352(a) - Section 502(a) of the FD&C Act", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding - Failure to comply with 510(k))" ] }, { "company": "Irvin, Inc.", "letter_id": "irvin-inc-612738", "date": "2021-05-27", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the FD&C Act]", "21 U.S.C. \u00a7 360(k) [Section 510(k) of the FD&C Act]; 21 U.S.C. \u00a7 352(o) [Section 502(o) of the FD&C Act]", "21 U.S.C. \u00a7 352(a) [Section 502(a) of the FD&C Act]; 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) [Section 502(a) of the FD&C Act]" ] }, { "company": "Mask Supply Store", "letter_id": "mask-supply-store-612585", "date": "2021-05-21", "device": "", "risk_score": 92, "deficiency_count": 7, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Requirements)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR 807 Subpart E", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / FDA Logo Policy", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act", "21 CFR Part 820 (Quality System Regulation) / Section 501(f)(1)(B) of the FD&C Act" ] }, { "company": "Nikkiso Medical America, Inc", "letter_id": "nikkiso-medical-america-inc-613109", "date": "2021-05-07", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act; 21 CFR 807.81(a)(3)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act", "21 CFR 807.81(a)(3)" ] }, { "company": "Baltimore Beauty Security Square Mall", "letter_id": "baltimore-beauty-security-square-mall-614182", "date": "2021-05-04", "device": "", "risk_score": 92, "deficiency_count": 3, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) (Section 515(a) of the FD&C Act) - Premarket Approval", "21 U.S.C. \u00a7 360(k) (Section 510(k) of the FD&C Act) - Premarket Notification", "21 U.S.C. \u00a7 331(a) and 331(k) (Sections 301(a) and 301(k) of the FD&C Act) - Prohibited Acts" ] }, { "company": "Manhattan Stitching Company, Inc.", "letter_id": "manhattan-stitching-company-inc-611719", "date": "2021-04-13", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 U.S.C. \u00a7 360(k) / Section 510(k)", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "21 U.S.C. \u00a7 321(h) / Section 201(h) of the FD&C Act" ] }, { "company": "Shenzhen Weifa Technology Co., Ltd", "letter_id": "shenzhen-weifa-technology-co-ltd-609828", "date": "2021-03-11", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act \u2014 Premarket Notification", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act \u2014 Misbranding (False or Misleading Labeling)", "21 CFR 807.39 \u2014 Misrepresentation of Registration and Listing", "FDA Logo Policy / 21 U.S.C. \u00a7 352(a)" ] }, { "company": "Workswell Group s.r.o.", "letter_id": "workswell-group-sro-613567", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the FD&C Act] / 21 CFR Part 807 Subpart E", "21 U.S.C. \u00a7 352(o) [Section 502(o) of the FD&C Act] / 21 CFR 807.81", "21 U.S.C. \u00a7 331(a) [Section 301(a) of the FD&C Act]", "21 CFR 801 / 21 U.S.C. \u00a7 352 [Section 502 of the FD&C Act]", "21 CFR 820 (Quality System Regulation) / FDA Enforcement Policy for Telethermographic Systems", "21 U.S.C. \u00a7 360 [Section 510 of the FD&C Act] / 21 CFR 807" ] }, { "company": "Shenzhen Sunell Technology Corporation", "letter_id": "shenzhen-sunell-technology-corporation-613563", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) \u2014 Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) \u2014 Section 502(o) of the FD&C Act (Misbranding); 21 U.S.C. \u00a7 360(k) \u2014 Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 331(a) \u2014 Section 301(a) of the FD&C Act (Prohibited Acts)", "21 CFR 801 \u2014 Labeling; Section 201(h) of the FD&C Act, 21 U.S.C. \u00a7 321(h)" ] }, { "company": "Certify Global Inc.", "letter_id": "certify-global-inc-613568", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding) / 21 CFR 807 Subpart E (Premarket Notification - 510(k))", "21 U.S.C. \u00a7 331(a) - Section 301(a) of the FD&C Act (Prohibited Acts)", "21 CFR 820.198 / 21 CFR 801 (Labeling and Promotional Claims)", "21 CFR 820.30 (Design Controls) / 21 U.S.C. \u00a7 360e(a)" ] }, { "company": "Cantronic Systems Inc.", "letter_id": "cantronic-systems-inc-613542", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2014 Adulteration", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act \u2014 Misbranding (failure to submit 510(k))", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act \u2014 Prohibited Acts (introduction of adulterated/misbranded devices into interstate commerce)", "21 CFR 807 / Section 510(k) of the FD&C Act \u2014 Establishment Registration and Device Listing", "21 CFR 820 (Quality System Regulation) \u2014 General" ] }, { "company": "Omnisense Systems Pte Ltd.", "letter_id": "omnisense-systems-pte-ltd-613561", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / 21 CFR Part 814 (Premarket Approval)", "21 U.S.C. \u00a7 360(k) / 21 CFR Part 807 Subpart E (Premarket Notification)", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act", "21 CFR Part 801 / 21 U.S.C. \u00a7 352 (Misbranding \u2013 Labeling and Promotional Claims)", "FDA Guidance: Enforcement Policy for Telethermographic Systems During COVID-19" ] }, { "company": "Thermoteknix System Limited", "letter_id": "thermoteknix-system-limited-613565", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 U.S.C. \u00a7 360(k) / Section 510(k)", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act", "FDA Enforcement Policy for Telethermographic Systems (COVID-19 EUA/Guidance Framework)", "21 CFR 807 (Establishment Registration and Device Listing)" ] }, { "company": "Kogniz, Inc.", "letter_id": "kogniz-inc-613569", "date": "2021-03-04", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act / 21 CFR 807 (Section 510(k))", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act", "21 CFR 820.30 (Design Controls) / ISO 14971 (Risk Management)" ] }, { "company": "Marci Beauty LLC", "letter_id": "marci-beauty-llc-612041", "date": "2021-02-02", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / Section 515(a) of the FD&C Act \u2014 Premarket Approval (PMA)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act \u2014 Misbranding (failure to submit 510(k))", "21 U.S.C. \u00a7 321(h) / Section 201(h) of the FD&C Act \u2014 Device Definition / Intended Use Claims", "21 CFR 807.81(b) \u2014 Premarket Notification Procedures" ] }, { "company": "EnMed MicroAnalytics, Inc.", "letter_id": "enmed-microanalytics-inc-610131", "date": "2021-01-25", "device": "", "risk_score": 92, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) \u2014 Section 501(f)(1)(B) of the FD&C Act (Adulteration \u2014 No PMA/IDE)", "21 U.S.C. \u00a7 352(o) \u2014 Section 502(o) of the FD&C Act (Misbranding \u2014 Failure to file 510(k))", "21 U.S.C. \u00a7 331(a) and 331(k) \u2014 Sections 301(a) and 301(k) of the FD&C Act (Prohibited Acts)", "21 CFR 807 \u2014 Establishment Registration and Device Listing (implied)" ] }, { "company": "ExThera Medical Corporation", "letter_id": "exthera-medical-corporation-715068", "date": "2026-02-06", "device": "", "risk_score": 90, "deficiency_count": 2, "top_clauses": [ "21 CFR 812.35(a)(1)", "21 CFR 812.40, 21 CFR 812.46(a)" ] }, { "company": "Diasol, Inc.", "letter_id": "diasol-inc-719460", "date": "2026-01-29", "device": "Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters", "risk_score": 90, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.80(d)", "21 CFR 820.75(a)" ] }, { "company": "Abbott Diabetes Care, Inc.", "letter_id": "abbott-diabetes-care-inc-722046", "date": "2026-01-23", "device": "FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System", "risk_score": 90, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.30(h)", "21 CFR 820.80(d)", "21 CFR 820.250(a)" ] }, { "company": "Opgal Optronic Industries Ltd.", "letter_id": "opgal-optronic-industries-ltd-613562", "date": "2021-03-04", "device": "", "risk_score": 90, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) [Section 501(f)(1)(B) of the FD&C Act] \u2014 Adulteration: No PMA, 510(k), or Emergency Use Authorization", "21 U.S.C. \u00a7 352(o) [Section 502(o) of the FD&C Act] \u2014 Misbranding: Failure to submit 510(k) premarket notification", "21 U.S.C. \u00a7 331(a) [Section 301(a) of the FD&C Act] \u2014 Prohibited Acts: Introduction of adulterated/misbranded devices into interstate commerce", "21 CFR 801 \u2014 Labeling; Section 201(h) of the FD&C Act [21 U.S.C. \u00a7 321(h)] \u2014 Device intended use claims", "FDA Guidance: Enforcement Policy for Telethermographic Systems During COVID-19 \u2014 Public health risk from simultaneous multi-person scanning" ] }, { "company": "Westminster International Ltd", "letter_id": "westminster-international-ltd-613566", "date": "2021-03-04", "device": "", "risk_score": 90, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 360e(a) / 21 CFR Part 814 (Section 515(a) of the Act - PMA)", "21 U.S.C. \u00a7 360(k) / 21 CFR Part 807 Subpart E (Section 510(k) of the Act - Premarket Notification)", "21 U.S.C. \u00a7 331(a) (Section 301(a) of the Act - Prohibited Acts)", "21 U.S.C. \u00a7 352(o) / 21 CFR Part 801 (Section 502(o) of the Act - Misbranding)", "21 CFR Part 820.30 (Design Controls) / FDA Telethermographic Systems Guidance", "21 CFR 807.20 (Establishment Registration and Device Listing)" ] }, { "company": "Exactech, Inc.", "letter_id": "exactech-inc-669904", "date": "2024-01-19", "device": "Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Num", "risk_score": 89, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(g)", "21 CFR 803.17" ] }, { "company": "Physitemp Instruments, LLC", "letter_id": "physitemp-instruments-llc-717394", "date": "2025-11-12", "device": "", "risk_score": 88, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.80(d)", "21 CFR 820.90(a)" ] }, { "company": "Royal Philips", "letter_id": "royal-philips-709948", "date": "2025-09-09", "device": "", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.50", "21 CFR 820.198(a)", "21 CFR 820.50(a)(2)", "21 CFR 806.10" ] }, { "company": "Miach Orthopaedics", "letter_id": "miach-orthopaedics-709827", "date": "2025-08-19", "device": "BEAR Implant. Model Number: 1000.", "risk_score": 88, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.75(b)", "21 CFR 820.90(a)", "21 CFR 820.30(c)" ] }, { "company": "LeMaitre Vascular, Inc.", "letter_id": "lemaitre-vascular-inc-713502", "date": "2025-08-11", "device": "LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli a", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.70(e)", "21 CFR 820.70(c)", "21 CFR 820.75(a)", "21 CFR 820.75(b)" ] }, { "company": "Onkos Surgical, Inc.", "letter_id": "onkos-surgical-inc-712573", "date": "2025-07-21", "device": "ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.50", "21 CFR 820.50 / ISO 13485:2016 Clause 7.5.6 (Process Validation)", "21 CFR 820.50 / ISO 13485:2016 Clause 7.5.6" ] }, { "company": "Visgeneer, Inc", "letter_id": "visgeneer-inc-709010", "date": "2025-06-13", "device": "Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)", "risk_score": 88, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.198(a)" ] }, { "company": "Reset Technology Corporation", "letter_id": "reset-technology-corporation-704828", "date": "2025-06-09", "device": "", "risk_score": 88, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.90(a)", "21 CFR 820.90(b)(2)" ] }, { "company": "Sedecal S.A.", "letter_id": "sedecal-sa-707156", "date": "2025-05-05", "device": "Sedecal NOVA FA DR System. for diagnostic radiography.", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(g)", "21 CFR 806.10", "21 CFR 1002.30(a)(1)" ] }, { "company": "Xoran Technologies, LLC", "letter_id": "xoran-694229", "date": "2024-12-09", "device": "MiniCAT CT Scanner (Class II)", "risk_score": 88, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.50", "21 CFR 820.30(g)", "21 CFR 820.198(a)" ] }, { "company": "Randox Laboratories Limited", "letter_id": "randox-laboratories-limited-696569", "date": "2024-12-06", "device": "Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is", "risk_score": 88, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.100(a)" ] }, { "company": "Argon Medical Productions & Vertrieb Gesellschaft MBH & CO", "letter_id": "argon-medical-productions-vertrieb-gesellschaft-mbh-co-694763", "date": "2024-11-22", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.198(c)", "21 CFR 803.17(a)", "21 CFR 803.50(a)(1)", "21 CFR 801.20(a), 21 CFR 801.40(a)(1), 21 CFR 801.40(a)(2)", "21 CFR 830.300(a), 21 CFR 830.320(b)" ] }, { "company": "Owens & Minor, Inc. dba American Contract Systems, Inc.", "letter_id": "owens-minor-inc-dba-american-contract-systems-inc-695683", "date": "2024-11-01", "device": "FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.80(b)", "21 CFR 820.30(a)", "21 CFR 820.30(g)", "21 CFR 820.30(j)" ] }, { "company": "Adept Medical Ltd.", "letter_id": "adept-medical-ltd-692226", "date": "2024-10-11", "device": "Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.80(a)", "21 CFR 820.75(a)", "21 CFR 820.100", "21 CFR 820.90(a)" ] }, { "company": "Micro-X Ltd.", "letter_id": "micro-x-692084", "date": "2024-09-10", "device": "Rover Mobile X-ray (Class II)", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.30(i)", "21 CFR 820.30(g)", "21 CFR 820.100(a)", "21 CFR 820.198(a)(3)", "21 CFR 806.10(a)", "21 CFR 1003.10(a)" ] }, { "company": "Augustine Temperature Management, LLC", "letter_id": "augustine-temperature-management-llc-671243", "date": "2024-03-21", "device": "Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and M", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 803.17", "21 CFR 803.50(a)(1)", "21 CFR 806.10", "21 CFR 820.80(b)" ] }, { "company": "Beckman Coulter Inc.", "letter_id": "beckman-coulter-inc-678042", "date": "2024-03-15", "device": "Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs addit", "risk_score": 88, "deficiency_count": 9, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.100(a)" ] }, { "company": "Techlem Medical Corporation", "letter_id": "techlem-medical-corporation-671395", "date": "2023-12-26", "device": "", "risk_score": 88, "deficiency_count": 8, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.22", "21 CFR 820.30(j)", "21 CFR 820.80(e)", "21 CFR 820.184", "21 CFR 820.50(a)", "21 CFR 820.40(b)", "21 CFR 801.20(a) / 21 CFR 830.300(a) / 21 CFR 830.320(b)" ] }, { "company": "Deymed Diagnostic s.r.o.", "letter_id": "deymed-diagnostic-sro-671076", "date": "2023-11-07", "device": "", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.30(a)", "21 CFR 820.198(a)", "21 CFR 820.70(a)", "21 CFR 820.184" ] }, { "company": "ReNovo, Inc. DBA Provision Device Reprocessing Solutions", "letter_id": "renovo-inc-dba-provision-device-reprocessing-solutions-664014", "date": "2023-10-13", "device": "Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Repr", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the Act; 21 CFR 807.81(a)(3)(i)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the Act; 21 U.S.C. \u00a7 360(k)", "21 CFR 820.90(a)", "21 CFR 820.70(c)" ] }, { "company": "Caltag Medsystems Ltd", "letter_id": "caltag-medsystems-ltd-662115", "date": "2023-08-31", "device": "", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.100", "21 CFR 820.30(e)", "21 CFR 820.30(h)", "21 CFR 820.75(a)", "21 CFR 820.72(a)", "21 CFR 820.120(b)" ] }, { "company": "Biosensors Interventional Technologies Pte Ltd", "letter_id": "biosensors-interventional-technologies-pte-ltd-662943", "date": "2023-07-21", "device": "", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 803.17(a)(1)", "21 CFR 803.50(a)(1)", "21 CFR 803.50(a)(2)", "21 CFR 820.100(a)" ] }, { "company": "Vitang Technology LLC", "letter_id": "vitang-technology-llc-653455", "date": "2023-06-12", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 CFR 807.81(a)(3) / Section 510(k) of the Act", "21 CFR 820.198", "21 CFR 820.70(i)", "21 CFR 820.50(a)", "21 CFR 820.75(a) and 21 CFR 820.75(b)" ] }, { "company": "Future Diagnostics Solutions B.V.", "letter_id": "future-diagnostics-solutions-bv-653493", "date": "2023-05-11", "device": "Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.100(a)(4)", "21 CFR 820.90(a)", "21 CFR 820.250", "21 CFR 820.22", "21 CFR 803.17(a)", "21 CFR 803.50(a)(2)" ] }, { "company": "Cutera, Inc.", "letter_id": "cutera-inc-639552", "date": "2023-02-08", "device": "Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act; 21 U.S.C. \u00a7 360e(a) - Section 515(a) PMA requirement", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act; 21 U.S.C. \u00a7 360(k) - Section 510(k); 21 CFR 807.81(a)(3)(ii)", "21 CFR 807.81(a)(3)(ii) - Premarket Notification for Major Changes", "21 CFR 820.30 (Design Controls) - implied; promotional materials reflect intended use changes without proper design control" ] }, { "company": "Turkuaz Sa\u011flik Hizmetleri Medikal Temizlik Kimyasa", "letter_id": "turkuaz-sa\u011flik-hizmetleri-medikal-temizlik-kimyasa-649158", "date": "2022-12-29", "device": "", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.198(a)", "21 CFR 820.50(a)", "21 CFR 820.30(i)", "21 CFR 820.70(d)", "21 CFR 820.25(a)" ] }, { "company": "Med Pen Concepts, LLC", "letter_id": "med-pen-concepts-llc-632974", "date": "2022-09-15", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.30(i)", "21 CFR 820.100(a)", "21 CFR 820.198", "21 CFR 820.80(b)", "21 CFR 820.184" ] }, { "company": "DeVilbiss Healthcare LLC", "letter_id": "devilbiss-healthcare-llc-619182", "date": "2021-11-23", "device": "125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB", "risk_score": 88, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.30(f)", "21 CFR 820.198(a)", "21 CFR 820.100(a)", "21 CFR 820.198(c)" ] }, { "company": "Invacare Corporation", "letter_id": "invacare-corporation-617319", "date": "2021-11-18", "device": "Bariatric Bed - BARPKG-IVC 1633", "risk_score": 88, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.198(c)", "21 CFR 820.198(a)", "21 CFR 820.100(a)(1)", "21 CFR 820.100(a)", "21 CFR 803" ] }, { "company": "Dongguan City Xinyuan Nonwoven Co., Ltd.", "letter_id": "dongguan-city-xinyuan-nonwoven-co-ltd-612354", "date": "2021-05-27", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Requirements)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act / 21 CFR Part 807 Subpart E", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act / 21 CFR 807.39", "FDA Logo Policy / 21 CFR 807.39", "21 CFR Part 807 (Establishment Registration and Device Listing)" ] }, { "company": "Dubak Electrical Group", "letter_id": "dubak-electrical-group-613511", "date": "2021-03-04", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding)", "21 U.S.C. \u00a7 331(a) - Section 301(a) of the FD&C Act (Prohibited Acts)", "21 CFR 807 - Establishment Registration and Device Listing / 21 CFR 820 - Quality System Regulation", "21 CFR 801 - Labeling / Section 502 of the FD&C Act" ] }, { "company": "Thermavis", "letter_id": "thermavis-613564", "date": "2021-03-04", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding); 21 U.S.C. \u00a7 360(k) - Section 510(k) of the FD&C Act", "21 U.S.C. \u00a7 331(a) - Section 301(a) of the FD&C Act (Prohibited Acts)", "21 CFR 801 (Labeling) / Section 201(h) of the FD&C Act", "21 CFR 820.30 (Design Controls) - implied absence" ] }, { "company": "CreativeStar Solutions", "letter_id": "creativestar-solutions-613535", "date": "2021-03-04", "device": "", "risk_score": 88, "deficiency_count": 5, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) - Section 501(f)(1)(B) of the FD&C Act (Adulteration)", "21 U.S.C. \u00a7 352(o) - Section 502(o) of the FD&C Act (Misbranding)", "21 U.S.C. \u00a7 331(a) - Section 301(a) of the FD&C Act (Prohibited Acts)", "21 CFR 801 - Labeling / Section 502 of the FD&C Act", "21 CFR 820.30 / FDA Telethermographic Guidance" ] }, { "company": "Flextronics America LLC", "letter_id": "flextronics-america-llc-722180", "date": "2026-01-27", "device": "", "risk_score": 85, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.100(a)" ] }, { "company": "MAST Biosurgery USA, Inc.", "letter_id": "mast-biosurgery-usa-inc-720661", "date": "2025-12-17", "device": "The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is th", "risk_score": 85, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.70(e)", "21 CFR 820.198(a)", "21 CFR 803.50(a)(1)" ] }, { "company": "ASP Global, LLC (Anatomy Supply Partners)", "letter_id": "asp-global-718444", "date": "2025-12-09", "device": "Capillary Blood Collection Tubes (Class II)", "risk_score": 85, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.50", "21 CFR 803.17(a)(3)" ] }, { "company": "Insung Medical Co. Ltd.", "letter_id": "insung-medical-co-ltd-712545", "date": "2025-09-23", "device": "", "risk_score": 85, "deficiency_count": 3, "top_clauses": [ "21 CFR 803.50(a)(2)", "21 CFR 803.17(a)(1)", "21 CFR 803.17(a)(3)" ] }, { "company": "MicroVention Costa Rica S.R.L.", "letter_id": "microvention-costa-rica-srl-643188", "date": "2022-09-30", "device": "", "risk_score": 85, "deficiency_count": 5, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.100", "21 CFR 820.100(a)(1)", "21 CFR 820.90(a)" ] }, { "company": "Omega Engineering Inc.", "letter_id": "omega-engineering-inc-613560", "date": "2021-03-04", "device": "Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.", "risk_score": 85, "deficiency_count": 4, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act \u2014 Adulteration (No PMA, 510(k), or Emergency Use Authorization)", "21 U.S.C. \u00a7 352(o) / Section 502(o) of the FD&C Act \u2014 Misbranding (Failure to submit 510(k) premarket notification)", "21 U.S.C. \u00a7 331(a) / Section 301(a) of the FD&C Act \u2014 Prohibited Act (Introduction of adulterated/misbranded device into interstate commerce)", "21 CFR 801 / Section 201(h) of the FD&C Act \u2014 Intended Use / Labeling and Promotional Claims" ] }, { "company": "Qianjiang Kingphar Medical Material Co Ltd.", "letter_id": "qianjiang-kingphar-medical-material-co-ltd-716715", "date": "2025-10-03", "device": "", "risk_score": 82, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.70(e)", "21 CFR 820.70(c)" ] }, { "company": "DFI Co., Ltd.", "letter_id": "dfi-co-ltd-705464", "date": "2025-05-06", "device": "", "risk_score": 82, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.198(a)", "21 CFR 820.90", "21 CFR 820.120" ] }, { "company": "Wissner-Bosserhoff GmbH", "letter_id": "wissner-bosserhoff-gmbh-690242", "date": "2024-08-30", "device": "SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198", "risk_score": 82, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.72(a)", "21 CFR 820.100(a)", "21 CFR 820.50(a)", "21 CFR 820.30(d)", "21 CFR 820.80(b)", "21 CFR 820.40" ] }, { "company": "Sonesta Medical AB", "letter_id": "sonesta-medical-ab-667325", "date": "2023-09-22", "device": "Sonesta S2; Article numbers: 525-S2-110V and 525\u00bf\u00bfS2-220V", "risk_score": 82, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.50(a)", "21 CFR 820.198(a)", "21 CFR 820.30(c)", "21 CFR 820.30(g)", "21 CFR 820.30(i)", "21 CFR 820.40" ] }, { "company": "Neitz Instruments Company Ltd.", "letter_id": "neitz-instruments-company-ltd-664336", "date": "2023-08-25", "device": "", "risk_score": 82, "deficiency_count": 6, "top_clauses": [ "21 CFR 803.17", "21 CFR 803.17(a)(1)", "21 CFR 803.17(a)(2)", "21 CFR 803.17(a)(3)", "21 CFR 803.17(b) / 21 CFR 803.18(b)(1)(i)", "21 CFR 803.12(a)" ] }, { "company": "Ming Fai Industrial Co LTD", "letter_id": "ming-fai-industrial-co-ltd-660075", "date": "2023-06-01", "device": "", "risk_score": 82, "deficiency_count": 2, "top_clauses": [ "21 CFR 820.75(a)", "21 CFR 820.86" ] }, { "company": "I.T.S. GmbH", "letter_id": "its-gmbh-657885", "date": "2023-05-19", "device": "Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has ", "risk_score": 82, "deficiency_count": 3, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.184", "21 CFR 803.17" ] }, { "company": "Fischer Analysen Instrumente Gmbh", "letter_id": "fischer-analysen-instrumente-gmbh-650388", "date": "2023-02-03", "device": "", "risk_score": 82, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.100(a)", "21 CFR 820.198", "21 CFR 820.70(i)" ] }, { "company": "Olympus Medical Systems Corporation", "letter_id": "olympus-medical-systems-corporation-649726", "date": "2022-12-12", "device": "", "risk_score": 82, "deficiency_count": 1, "top_clauses": [ "21 CFR 803.50(a)(2)" ] }, { "company": "Aizu Olympus Co., Ltd.", "letter_id": "aizu-olympus-co-ltd-643172", "date": "2022-11-02", "device": "PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE", "risk_score": 82, "deficiency_count": 4, "top_clauses": [ "21 CFR 820.30(g)", "21 CFR 820.75(a)", "21 CFR 820.184", "21 CFR 803.17" ] }, { "company": "Magnolia Medical Technologies, Inc.", "letter_id": "magnolia-medical-technologies-inc-617922", "date": "2021-09-17", "device": "The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN\t/ Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN\t/ Steripath Gen2 Blood Collection System - 23G,", "risk_score": 82, "deficiency_count": 6, "top_clauses": [ "21 CFR 820.100(a)", "21 CFR 820.30(f)", "21 CFR 820.70(a)" ] }, { "company": "Fixture Display LLC", "letter_id": "fixture-display-llc-615052", "date": "2021-06-28", "device": "", "risk_score": 82, "deficiency_count": 6, "top_clauses": [ "21 U.S.C. \u00a7 351(f)(1)(B) / Section 501(f)(1)(B) of the FD&C Act (Premarket Requirements)", "21 U.S.C. \u00a7 360(k) / Section 510(k) of the FD&C Act; 21 CFR Part 807 Subpart E", "21 U.S.C. \u00a7 352(a) / Section 502(a) of the FD&C Act; 21 CFR 807.39", "FDA Logo Policy; 21 CFR 807.39", "21 U.S.C. \u00a7 360bbb-3 / Section 564 of the FD&C Act (EUA Conditions)" ] }, { "company": "Forcemech International LLC", "letter_id": "forcemech-international-llc-634891", "date": "2022-09-21", "device": "", "risk_score": 78, "deficiency_count": 7, "top_clauses": [ "21 CFR 820.181(d)", "21 CFR 820.120", "21 CFR 820.80(a)", "21 CFR 820.40", "21 CFR 820.200(a)", "21 CFR 801.20(a) / 21 CFR Part 830", "21 CFR 830.300(a)" ] }, { "company": "Wello Inc.", "letter_id": "wello-inc-664806", "date": "2023-11-08", "device": "", "risk_score": 62, "deficiency_count": 2, "top_clauses": [ "21 CFR 801.20(a), 21 CFR 801.40(a)(1), 21 CFR 801.40(a)(2), 21 CFR Part 830", "21 CFR 830.300(a), 21 CFR 830.320(b), 21 CFR Part 830 Subpart E" ] } ], "linkedin_summary": "Analysis of 224 FDA medical device warning letters (2021-2026) reveals 1152 total compliance deficiencies across 219 companies. The average risk score is 91.8/100, with 170 letters rated critical (90+). The most frequently cited QMSR clauses are ISO 13485:2016 Clause 8.5.2 / 8.5.3 and ISO 13485:2016 Clause 8.2.2. Severity distribution: 966 critical, 185 major, 1 minor findings. These patterns indicate systemic industry challenges in QMSR transition readiness, particularly around design controls, CAPA effectiveness, and process validation." }