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

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    MEDICAL X-RAY FILM

    FDA 510(k)
    FDA Class 1 ·Radiology

    FMX314 Surgical Platform

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

    NAKED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2014

    PRECISION XTRA

    FDA Adverse Event
    Injury ·Product code NBW·October 7, 2010

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·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