BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    CSM CHROMOGENIC B-LACTAMASE DISC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788229300·9 mm Small Hudson Shaver

    Evolve Nitric Oxide Delivery System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYTOMEGALO VIRUS & CONTROLS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENDURON 10D 54OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code JWH·March 23, 2015

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 5, 2014

    CAPS-LOCK CANNULA

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·October 23, 2012

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 1, 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