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

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    INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M COLD/HOT WATER BAG AND WRAP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CADD CASSETTE RESERVOIRS - FLOW STOP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD,INC.·Product code FPA·November 6, 2019

    EDGE CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·December 21, 2012

    ENDEAVOR RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·October 29, 2010

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014

    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