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

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    OB TILT TABLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788231490·Right Straight Cup Curette, Toothed

    SERVO-I VENTILATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    S/P VORTEX MIXER JR.

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    NEXSITE HD

    FDA Adverse Event
    Malfunction ·MARVAO MEDICAL·Product code MSD·May 21, 2014

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 7, 2012

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 6, 2015

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023

    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