BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    SANIFIX

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MYOCARDIAL INSULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROVIDER U-100 INSULIN INFUSION SYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·October 21, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 21, 2012

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 14, 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