BEUDAMED
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    SELF-CONTAINED MOBILE OPHTHAL. OPER. .

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788224270·Cervical Trial + DS 8x18x14 Flat

    CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONTOUR SE MICROSPHERES

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    TRILOGY LONGEVITY POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·November 2, 2012

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 26, 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