BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    THUMPER (VIBRATOR/MASSAGER)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Active-X Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGGREGOMETER, DUAL CHANNEL PLATELET

    FDA 510(k)
    FDA Class 2 ·Hematology

    CAPSUREFIX NOVUS

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

    SYBRONPRO TL

    FDA Adverse Event
    Injury ·EBI INC.·Product code DZE·October 7, 2010

    LIGASURE ADVANCE PISTOL GRIP

    FDA Adverse Event
    Injury ·COVIDIEN LP·Product code GEI·November 30, 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