BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    GLUCOFACTS DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Matrix Pre-Treatment Controller

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPRINT QUATTRO SECURE S

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

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    APOGEE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 27, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    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