BEUDAMED
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    MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CODMAN® HOLTER®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515531·CODMAN® HOLTER® Type B Fixation and Joining Con...

    CODMAN HOLTER

    FDA UDI
    Cerenovus, Inc.·10886704040743·CODMAN HOLTER Type B Fixation and Joining Conne...

    PROGRAMMABLE VALVE SYSTEM SPECIAL DEVICE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·August 14, 2006

    EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ERCHONIA ZERONA

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

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·November 6, 2012

    OT ULTRAMINI

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code MDS·August 31, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 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