BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mbrace Cable

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOHELIX SYNDESMOSIS FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PM-8000 PATIENT MONITOR, MODEL 8000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROVISC

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.·Product code LZP·November 14, 2008

    GOBED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 19, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025