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Division of Medical Device and Radiological Health Operations East

4 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Criticare Technologies, Inc. - FDA Warning Letter (2024-07-12)2024-07-12
Abiomed Inc. - FDA Warning Letter (2023-09-19)2023-09-19
Tesla BioHealing, Inc. - FDA Warning Letter (2023-08-10)2023-08-10
RightEye, LLC - FDA Warning Letter (2022-12-20)2022-12-20

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