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

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    KERMATH THERAPY SIMULATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581272600001·A-FIT® 2. MOLAR UPR LFT SZ 26

    PROSAFE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SONIX ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATTAIN ABILITY

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    J-VAC RESERVOIR

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

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

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