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

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    VarioSurg 4

    FDA 510(k)
    FDA Class 2 ·Dental

    EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T2 Alpha Femur Retrograde Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENTAK PRIZM HE VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    TAXUS (R) LIBERTÉ (R)

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 19, 2011

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·July 25, 2013

    ACCOLADE DR SL MRI (Model L311)

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