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

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    TOTAL FINGER FLEXION SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Surgical Face Mask

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

    HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·November 27, 2007

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 7, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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