BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    PREP TRAY, PREOPERATIVE SKIN

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

    Philips CT Big Bore Sliding Gantry Configuration

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMAGE STORAGE SYSTEM, MODEL KSS-400

    FDA 510(k)
    FDA Class 2 ·Radiology

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014

    PCA PLS II

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 5, 2012

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 16, 2015

    PROPONENT DR SL (Model L201)

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