BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    CARBON DIOXIDE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECICE System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GO-BETWEEN

    FDA 510(k)
    FDA Class 1 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 13, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·December 13, 2012

    GIRAFFE INCUBATOR

    FDA Adverse Event
    Malfunction ·GENERAL ELECTRIC HEALTHCARE·Product code FMZ·September 28, 2010

    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