BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SILGMANN SOLARIUM SUN-MOBIL MODEL 0918

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

    BLOOD CELL PROCESSOR MODEL 2 IBM 2991

    FDA 510(k)
    FDA Class 2 ·Hematology

    SpineView X-Pac Expandable Lumbar Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A. (SMO)·Product code LWS·June 10, 2014

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 6, 2012

    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

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014