BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)

    FDA 510(k)
    FDA Class 2 ·Dental

    POSITIVE DISPLACEMENT SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENDEAVOR RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·June 10, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 6, 2012

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 7, 2010

    MENISCAL DEPLOYMENT GUN

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEF·January 16, 2019

    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