BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    COMMAND ULTRA I

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023140·Wand - Outer, 4in

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023160·Wand - Outer, 6in

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023120·Wand - Outer, 2in

    DIASOL-ADDITIVES

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

    EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2014

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 31, 2012

    PENUMBRA SYSTEM 5MAXACE REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·June 4, 2015

    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