Atlas FDA

Office of Biological Products Operations – Division 2

7 FDA 510(k) clearances · Issuing office

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RecordFirmDate
BioLab Sciences, Inc. - FDA Warning Letter (2022-08-23)2022-08-23
Vitti Labs, LLC - FDA Warning Letter (2022-07-28)2022-07-28
Re-Gen Active Lab, Inc. - FDA Warning Letter (2022-05-27)2022-05-27
Smart Surgical, Inc dba Burst Biologics - FDA Warning Letter (2022-02-02)2022-02-02
Cooper Institute - FDA Warning Letter (2021-12-15)2021-12-15
Surgenex LLC - FDA Warning Letter (2021-11-15)2021-11-15
Utah Cord Bank LLC dba Utah Cell Bank - FDA Warning Letter (2021-08-10)2021-08-10

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