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

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    ARGYLE FERGUSON LEFT ATRIAL VENT CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TETRACHROME REAGENTS AND TETRACXP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    NAV LUMBAR PROBE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·May 20, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    HENRY SCHEIN EARLOOP FACE MASKS

    FDA Adverse Event
    Injury ·A.R. MEDICOM, INC.·Product code FXX·August 25, 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