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Center for Biologics Evaluation and Research

13 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Estar Technologies Ltd - FDA Warning Letter (2026-04-22)2026-04-22
Dynamic Stem Cell Therapy - FDA Warning Letter (2026-02-11)2026-02-11
Louisville Reproductive Center - FDA Warning Letter (2026-01-23)2026-01-23
Platinum Biologics LLC - FDA Warning Letter (2025-08-15)2025-08-15
InVia Fertility Specialists, PLLC - FDA Warning Letter (2025-06-13)2025-06-13
Supreme Rejuvenation, LLC - FDA Warning Letter (2025-05-05)2025-05-05
Amy Lightner, MD - FDA Warning Letter (2025-03-25)2025-03-25
Evolutionary Biologics Inc. - FDA Warning Letter (2024-12-30)2024-12-30
Frontier Biologics, LLC - FDA Warning Letter (2024-11-01)2024-11-01
Regenerative Processing Plant, LLC - FDA Warning Letter (2024-08-16)2024-08-16
CARsgen Therapeutics Corporation - FDA Warning Letter (2024-07-26)2024-07-26
Toxikon Corporation/Labcorp Bedford LLC - FDA Warning Letter (2022-02-10)2022-02-10
Davati Medical Supply LLC - FDA Warning Letter (2021-06-25)2021-06-25

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