BEUDAMED
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    LEGIONELLA PNEUMOPHILA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    REGISTRADO X-TRA

    FDA 510(k)
    FDA Class 2 ·Dental

    M2A-MAGNUM MOD HD SZ 42MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US·Product code LFL·October 9, 2012

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE, LLC.·Product code NQO·August 30, 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