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Center for Biologics Evaluation and Research (CBER)

41 FDA 510(k) clearances · Issuing office

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◉ Watch Center for Biologics Evaluation and Research (CBER)

RecordFirmDate
R3 Medical Companies - FDA Warning Letter (2026-08-14)2026-08-14
Genzyme Ireland Limited - FDA Warning Letter (2026-06-22)2026-06-22
Blue Horizon International, LLC - FDA Warning Letter (2026-05-26)2026-05-26
4U Health - FDA Warning Letter (2026-03-17)2026-03-17
ProDx Health - FDA Warning Letter (2026-02-10)2026-02-10
Central Coast Multispecialty Medical Group, Inc. - FDA Warning Letter (2026-01-29)2026-01-29
Conceive Fertility Center - FDA Warning Letter (2026-01-27)2026-01-27
Germaphobix - FDA Warning Letter (2026-01-09)2026-01-09
Genetrace - FDA Warning Letter (2026-01-08)2026-01-08
Genovate - FDA Warning Letter (2026-01-08)2026-01-08
Green Valley Fertility Partners - FDA Warning Letter (2025-12-03)2025-12-03
Microvascular Tissue, Inc. - FDA Warning Letter (2025-12-03)2025-12-03
Allovate Therapeutics, LLC - FDA Warning Letter (2025-09-30)2025-09-30
New Life Medical Services, LLC - FDA Warning Letter (2025-09-24)2025-09-24
Cellebration LLC - FDA Warning Letter (2025-09-12)2025-09-12
CSL Behring - FDA Warning Letter (2025-09-09)2025-09-09
NuVida Medical LLC - FDA Warning Letter (2025-09-04)2025-09-04
Innate Healthcare Institute - FDA Warning Letter (2025-08-15)2025-08-15
O3UV, LLC - FDA Warning Letter (2025-07-07)2025-07-07
MG Infusions - FDA Warning Letter (2025-03-10)2025-03-10
Sperm Bank, Inc. dba Fertility Center of California - FDA Warning Letter (2025-02-14)2025-02-14
BioStem Life Sciences - FDA Warning Letter (2025-01-17)2025-01-17
Chara Biologics, Inc. - FDA Warning Letter (2025-01-17)2025-01-17
Skye Biologics Holdings LLC - FDA Warning Letter (2024-12-16)2024-12-16
INCELL Corporation LLC - FDA Warning Letter (2024-12-12)2024-12-12
XO Biologix, LLC - FDA Warning Letter (2024-12-12)2024-12-12
Blackfly Investments, LLC dba Molecular® Testing Labs - FDA Warning Letter (2024-10-11)2024-10-11
Namita A. Goyal, M.D. - FDA Warning Letter (2024-10-10)2024-10-10
Hemarus LLC - FDA Warning Letter (2024-10-08)2024-10-08
Pinnacle Transplant Technologies, LLC - FDA Warning Letter (2024-10-01)2024-10-01
Amnio Technology, LLC - FDA Warning Letter (2024-10-01)2024-10-01
Mother Stem Institute, Corp. - FDA Warning Letter (2024-08-20)2024-08-20
Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. - FDA Warning Letter (2024-06-28)2024-06-28
Massachusetts Institute of Technology MIT - FDA Warning Letter (2024-06-21)2024-06-21
Konrad Rejdak, M.D., Ph.D. - FDA Warning Letter (2024-05-29)2024-05-29
Human Microbes - FDA Warning Letter (2024-02-09)2024-02-09
Barkey GmbH & Co. KG - FDA Warning Letter (2024-01-31)2024-01-31
MiMedx Group, Inc. - FDA Warning Letter (2023-12-20)2023-12-20
Abbott Laboratories - FDA Warning Letter (2023-10-24)2023-10-24
Infinant Health, Inc formerly Evolve Biosystems Inc. - FDA Warning Letter (2023-09-28)2023-09-28
Valley Biosystems - FDA Warning Letter (2022-08-03)2022-08-03

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