Atlas FDA

Division of Biological Products Operations I

9 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Neobiosis, LLC - FDA Warning Letter (2024-06-05)2024-06-05
Washington Fertility Center - FDA Warning Letter (2024-04-30)2024-04-30
Fresenius Kabi AG - FDA Warning Letter (2023-09-14)2023-09-14
Kimera Labs, Inc. - FDA Warning Letter (2023-09-01)2023-09-01
The New Hope Center for Reproductive Medicine - FDA Warning Letter (2023-06-27)2023-06-27
Row1 Inc. dba Regenative Labs - FDA Warning Letter (2023-06-21)2023-06-21
RenatiLabs Inc. - FDA Warning Letter (2023-06-01)2023-06-01
Mark S. Denker, M.D., PA dba Palm Beach Fertility Center - FDA Warning Letter (2022-11-17)2022-11-17
Cryos International USA LLC - FDA Warning Letter (2022-10-24)2022-10-24

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Every clearance here is in the API, with alerts when new ones post.