BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    SELF RETAINING RETRACTOR FOR HAND SURG

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

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788202900·Screw Locker

    TOSHIBA 1.5T CARDIAC COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DASH 3000/4000 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·May 20, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 31, 2012

    OT SELECT METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·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