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

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    ROCHESTER PEAN FORCEPS CURVED 6 1/4

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Stradis

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821296·Custom Surgical Kit

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268212961·CUSTOM SURGICAL KIT VEIN PACK

    SIMPLICITY QD EASY P INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTERVENTIONAL WORKSPOT

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    PULSAR GENERATOR

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

    POSEY PERSONAL ALARM

    FDA Adverse Event
    Malfunction ·POSEY MEDICAL DEVICE LTD.·Product code KMI·August 26, 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