BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    OPUS IMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    API UNISCEPT MIC 100UL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PHACOTRON PLUS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2015

    BUCKY DIAGNOST TH

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS GMBH DMC·Product code KPR·February 6, 2014

    POLYAXIAL PEDICLE SCREW

    FDA Adverse Event
    Injury ·ZIMMER SPINE, INC.·Product code NKB·December 27, 2012

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

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