BEUDAMED
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    OSC-80 OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA® Chemistry B2M ß2-Microglobulin Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414590165·b2 Microglobulin - ADVIA Chem. - RGT - 2x100 t...

    GORE PROPATEN VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

    FDA 510(k)
    FDA Class 2 ·Neurology

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 8, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 29, 2012

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012