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OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality

3 FDA 510(k) clearances · Issuing office

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◉ Watch OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality

RecordFirmDate
Bioptimal International - FDA Warning Letter (2024-04-03)2024-04-03
Spectrum Medical Ltd - FDA Warning Letter (2023-09-29)2023-09-29
Biosensors Interventional Technologies Pte Ltd - FDA Warning Letter (2023-07-21)2023-07-21

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