BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    FOLEY INSERTION TRAYS W/OVERWRAY

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

    DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BMN I TYPE MARROW ASPIRATION NEEDLE

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

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2014

    MEDCOMP

    FDA Adverse Event
    Injury ·MEDICAL COMPONENTS, INC.·Product code DYB·October 30, 2012

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2007

    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