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

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    ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ATLAS

    Device
    EU MDR · Eu Md Class 1 ·ATLAS CERRAHİ ALETLER LTD. ŞTİ.·On the market·32 countries

    5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HydroSet XT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX MRI SURESCAN

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

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·December 7, 2012

    GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 22, 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