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

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    Powered Wheelchair (PL001-9001)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Visions PV.014P RX Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WRISTOX MODEL 3100 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·December 4, 2008

    SYNERGY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code JDH·September 19, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 29, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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