BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    FLEET DETECTATEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581272800001·A-FIT® 2. MOLAR UPR LFT SZ 28

    E-SCAN MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEPAIRX VENTILATING AIR PURIFIER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 15, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ETHILON NYLON SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAR·August 13, 2010

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

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