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

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    FORCE EVALUATION AND TESTING SYSTEM (FETS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONCOR EXPRESSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPRINT QUATTRO SECURE MRI SURESCAN

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

    ASAP ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXE·November 21, 2012

    REPAIR CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 21, 2010

    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