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

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    SternalPlate Expansion

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PicoLO Nd: YAG Picosecond Laser System

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

    ENFANTTM

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 11, 2014

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 27, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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