BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    HCT CENTRIFUGE

    FDA 510(k)
    FDA Class 2 ·Hematology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788224450·Cervical Trial +DS 6x14x12 Lordotic

    VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AESPIRE 7900, AESPIRE VIEW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOVIVE? STANDARD PEG KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·May 20, 2014

    UNI-KNEE HIGH-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·November 2, 2012

    SYNCHROMED II

    FDA Adverse Event
    Death ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 26, 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