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

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    PC 201A LOCKING SLEEVE

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

    MY BREAST FRIEND, BREAST SELF-EXAM PAD

    FDA 510(k)
    FDA Class 1 ·Radiology

    PEDIGUARD NERVE DETECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CLINITRON RITEHITE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code INX·February 28, 2014

    8 MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 7, 2012

    6F ANGIO-SEAL EVOLUTION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·August 25, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 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