BEUDAMED
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    PATIENT EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEMODIALYSIS BLOOD CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Safergel Sterile Ultrasound Gel

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·October 17, 2010

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·November 21, 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