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.

    KODAK X-OMATIC RA CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DePuy Synthes Plates and Screws Portfolio

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNIFY CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 1, 2010

    EON MINI

    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