BEUDAMED
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    ANA HEP-2 FLUORO-KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788223970·Cervical Rasp + DS 10x18x14 Flat

    LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SIGNA 3.0T MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 7, 2012

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GEI·August 17, 2007

    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