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

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    PRO-SCOPE

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

    Traverse

    FDA UDI
    Nuvasive, Inc.·00887517154484·Traverse Plate, 85mm 2-Bolt

    FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620855·FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    STINGRAY CERVICAL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014

    LINOX SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 9, 2012

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·August 22, 2010

    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