BEUDAMED
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    CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB

    FDA 510(k)
    FDA Class 2 ·Radiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756325813·CRYO TRAY PGYBK

    ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

    FDA 510(k)
    FDA Class 2 ·Hematology

    Yukon OCT Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 25, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 2, 2010

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 27, 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