BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CHEMO-PORT NON-CORING NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731651·GC Initial™ AL Correction Powder COR, 20g

    DRAD-3000E, RADREX-I

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACETABULAR CEMENT COMPRESSOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 18, 2010

    COULTER® AC T 5DIFF AL

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·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