BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    IMMUNO DIAGNOSTICS ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220260·16mm Lumbar Smooth Distractor

    FAC-3 - Class B 21 White Cap - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620268·FAC-3 - Class B 21 White Cap - 3 Shelf Cabinet

    MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PRISM ACQUIRE PRISM PROCESS PRISM VIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·October 9, 2012

    APLICARE

    FDA Adverse Event
    Malfunction ·APLICARE·Product code NEC·August 16, 2010

    BREATHING CIRCUIT SET

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code BZO·May 12, 2026

    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