BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    Vantage Galan 3T, V4.6

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ponto

    FDA UDI
    Oticon Medical AB·05712149013975·Ponto Soft band, indigo

    PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INTERCONTINENTAL PLATE-SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETS-FLEX - ENDOSCOPIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2013

    EMBOLECTOMY GRN 3FR TUBE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES,LLC·Product code DXE·September 23, 2014

    CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

    FDA 510(k)
    FDA Class 2 ·Neurology

    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