BEUDAMED
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    WANG FRONT LOADING APPLICATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 31, 2012

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV·Product code FNL·October 27, 2010

    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