BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPINOCAN SPINAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209117628·

    RUBICOR BREAST BIOPSY DEVICE

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

    CORAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·November 5, 2012

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·August 20, 2010

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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