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

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    MDM ARTERIAL BLOOD GAS KIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    072 Aspiration System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DVT60

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 7, 2014

    QUADROX-ID

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 2, 2012

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·August 30, 2010

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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