BEUDAMED
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    KINEMATIC II KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IdentiTi II

    FDA UDI
    ALPHATEC SPINE, INC.·00190376595740·ID II TLIF-A, 10mL SYRINGE ADAPTER

    SYNGO, BREAST CARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·November 7, 2012

    CATGUT PLAIN 3/0 (3) 75CM HR26

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code MPN·February 28, 2014

    OCTRODE TRIAL LEAD

    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