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

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    CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788223270·Cervical Trial 9x18x14 Lordotic

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M75268223270·

    NOVUS SPECTRA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VOLUSON E6/E8/E8EXPERT/E10

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·May 20, 2014

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/35MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 7, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·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