BEUDAMED
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    FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS

    FDA 510(k)
    FDA Class 1 ·Dental

    VIALOK SINGLE VIAL ACCESS DEVICE VENTED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIGHT TIP

    FDA 510(k)
    FDA Class 2 ·Dental

    WEBSTER QUADROPOLAR - FIXED

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012

    LARGE MOD HEAD ADAPT 12/14 +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWY·May 20, 2014

    BIOCOMPOSITE INTERFERENE SCREW, FULL THREAD

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·May 29, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 5, 2015

    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