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

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    IGNITE Bone Void Filler

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120697·4-LEVEL PLATE ASSEMBLY, 82MM

    COMBAT READY CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    AMPLATZER MUSCULAR VSD OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·June 26, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.8010379·Product code KWA·October 21, 2014

    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