BEUDAMED
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    ANATOMIC FRACTURE BRACE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ABBOTT ARCHITECT FOLATE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MULTILINK AUTOMIX

    FDA 510(k)
    FDA Class 2 ·Dental

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·March 26, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

    EON-IPG

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 25, 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