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

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    VITAL FLOW NASAL CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BOD POD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wingman 18 Crossing Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT FIDELIS

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    STERIS SYSTEM 1E

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·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