BEUDAMED
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    REAADS-RF TEST KIT-QUANTITATIVE

    FDA 510(k)
    FDA Class 2 ·Immunology

    mCare® Powder Free Nitrile Black Examination Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NORLAND MODEL 278 BONE DENSITOMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    KYPHON XPANDER II EU

    FDA Adverse Event
    Malfunction ·KYPHON NEUCHATEL·Product code HRX·June 24, 2014

    DIMENSION EXL® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·January 2, 2013

    SROM MARATHON LINER L 28 10DEG

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 3, 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