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

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    ELLISON VITALLIUM FIXATION STAPLE SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788229430·10 mm Small Hudson Distractor

    POSITIVE END EXPIRATORY PRESSURE VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX EMS DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 16, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 7, 2012

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 1, 2010

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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