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

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    VARUS AND VALGUS LEG HOLDER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PYRAMID® +4 Anterior Lumbar Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994470287·PLATE 9873139 3-HOLE 39MM

    PYRAMID® +4 Anterior Lumbar Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000888183·PLATE 9873139 3-HOLE 39MM

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731391·GC Initial™ AL Shoulder Opaq. SO-39, 20g

    SMALL LUMEN PERITONEAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·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