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

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    NON-REBREATHING TEE PIECE (NRTP)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    API STAPHASE III

    FDA 510(k)
    FDA Class 1 ·Microbiology

    S.E.T. TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALARIS PUMP MODULE

    FDA Adverse Event
    Death ·CAREFUSION CORP·Product code FRN·June 11, 2014

    EON IPG

    FDA Adverse Event
    Death ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·October 21, 2010

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·December 21, 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