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

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    HIGH PRESSURE CONNECTING SETS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Epicage Interbody Fusion System

    FDA UDI
    ALPHATEC SPINE, INC.·00840967190693·Midline Portal – 8mm

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077144·9W X 27L X 0° X 8H STRAIGHT TRIAL

    Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

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

    BIOPRO FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 4, 2015

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 24, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 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