BEUDAMED
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    GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PreView™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210920·PreView Plate Bender

    FLOWEASE [SUBCUTANEOUS] INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·May 20, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    PEDIPORT5.5MM SHORT SECONDARY PORT

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·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