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

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    E613 PAIR OF SUPPORT BLOCKS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

    FDA 510(k)
    FDA Class 2 ·Neurology

    OUCHTERLONY AGAR PLATES

    FDA 510(k)
    FDA Class 1 ·Immunology

    UNIFY QUADRA CRT-D

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 24, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·November 3, 2010

    STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 27, 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