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

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    UNIFAST CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731341·GC Initial™ AL Shoulder Transpa ST-34, 20g

    TOWNLEY™ Transfacetpedicular Screw Fixation System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490833240·UCS 4.0X34 X873-134 CANN LAG SCR TI

    A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SENTIO MMG Pedicle Access Needles

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 18, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·December 13, 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