BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MINIMED INSULIN PUMP, MODEL 505

    FDA 510(k)
    FDA Class 2 ·General Hospital

    A-GENT(TM) LIQUID GLUCOSE TRINDER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code FMJ·May 22, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·February 15, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 12, 2011

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021