BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    GRAM NEGATIVE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268215991·CUSTOM SURGICAL KIT PHLEB PACK

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

    CRIT-LINE CLIP (CLIC)

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

    96 CHANNEL EEG HEADBOX MODEL EMU96

    FDA 510(k)
    FDA Class 2 ·Neurology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 6, 2012

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    FDA Adverse Event
    Injury ·HOLLISTER INCORPORATED·Product code CBH·June 5, 2015

    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