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SynCardia Systems LLC

2 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO recall (Z-0126-2024)SynCardia Systems LLC2023-10-20
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Hear recall (Z-1022-2023)SynCardia Systems LLC2023-01-27

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