BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ENTERAL FEEDING TUBE

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

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077014·11MM STRAIGHT IMPLANT SHAFT ASSEMBLY

    FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

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

    CARDIOTOMY RESERVOIR CR-2000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·June 24, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 22, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012

    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