BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MANAN BONE MARROW BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HeartFlow FFRct Analysis

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTIPLE (APEX LOCATOR), MODEL RCM-7

    FDA 510(k)
    FDA Unclassified ·Unknown

    QUATTRODE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZF·June 4, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 28, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 21, 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