BEUDAMED
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    GILCHEM ACID PHOSPHATASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CS 8100 CS 8100 ACCESS

    FDA 510(k)
    FDA Class 2 ·Dental

    V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTICUL/EZE BALL 28 +8.5 BL

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043·Product code JDI·May 20, 2014

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·November 6, 2012

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·August 27, 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