BEUDAMED
    7 results · 19ms · 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 ×

    MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOBIN-VDDIN VEIN GRAFT HOLDER

    FDA 510(k)

    CORDIS PTA CATHETER-PERCUTANEOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUMA DESENSITIZER POWER GEL

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH·Product code LBH·June 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 4, 2012

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MTF·October 28, 2010

    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. 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 II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012