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

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    Arctic Sun Stat Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Esteya

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MAD NASAL

    FDA Adverse Event
    Malfunction ·WOLFE TORY MEDICAL, INC.·Product code CCQ·September 6, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025