BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    PolyWear® Personal Protective Level 3 Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EVOLVE CERAMIC RADIAL HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HipXpert 3D Display and Anchoring Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    WALRUS STOPCOCK AND MANI FOLD COMPONENT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code FMG·November 7, 2008

    UNKNOWN DEPUY DURALOC 28X58N LINER

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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