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

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    NEONATAL UNILET

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

    SMITH & NEPHEW MODULAR FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    12-9170 SERIES II TOTAL HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 13, 2014

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·October 1, 2010

    AFFINITY 3 BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code HDD·November 2, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012