BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    TRACOR RA400 AUDIOMETER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788224140·Cervical Trial + DS 11x14x12 Flat

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113669·PS-C Insert, Size 4 x 14mm

    AB COMMAND DUAL CHANNEL FITNESS BELT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    UNKNOWN ZIMMER KNEE COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 2, 2012

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·September 1, 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