BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    CONMED MACROLYTE DISPERSIVE ELECTRODE

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

    M'ATH STD

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INSYTE-N¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·January 17, 2023

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code OUT·May 31, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 15, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA·Product code LXH·August 28, 2008

    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