BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    MODIFIED INTENDED USE OF CLEANING REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Andwin Scientific

    FDA UDI
    Andwin Scientific·20187207000393·Andwin 7.5" Brush PK/500

    OXFORD EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iSLEEVE Introducer Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 24, 2014

    UNK SPINAL CORD STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·October 22, 2010

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 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