BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    INNOTRON FLUORIMETER SERIES ONE-10

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788229420·9 mm Small Hudson Distractor

    CRANIOCUT

    FDA 510(k)
    FDA Class 2 ·Neurology

    HITEMP. TM 2 LOOPTIP CAUTERY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 5, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 7, 2012

    FLO-GARD 6200 PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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