BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    LAUF-ERGOTEST

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Clarius Prostate AI

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDCARE WOUND CLOSURE TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RSP SHOULDER

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code KWS·June 2, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 23, 2012

    PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 12, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024