BEUDAMED
    2 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    FDA Enforcement
    Class II ·Ongoing·SynCardia Systems LLC·February 8, 2023

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Enforcement
    Class II ·Completed·SynCardia Systems LLC·November 1, 2023