BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    GORE-TES EXPANDED PTFE PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268217171·CUSTOM SURGICAL KIT VEIN PACK

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821717R11·CUSTOM SURGICAL KIT VEIN PACK

    Disposable Surgical Gown UM-148

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

    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5

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

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 20, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    MSERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·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