BEUDAMED
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    H. INFLUENZA B ANTISERA FOR CIE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575200733·3 hole flanges,with caudal flange

    MIDMARK M9 ULTRACLAVE STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEAR ALIGNER ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 20, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·November 7, 2012

    HILL-ROM 100 LOW BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 30, 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