BEUDAMED
    3 results · 51ms · Sources: EU EUDAMED, US FDA

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

    FDA Recall
    Completed ·SynCardia Systems LLC·Product code LOZ·August 1, 2023

    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·October 21, 2016

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

    FDA Recall
    Open, Classified ·SynCardia Systems LLC·Product code LOZ·November 2, 2022