BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    enspire 300 Series Automated Endoscope Reprocessor

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

    SENSE-4BABY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    C.T.M. MOBILITY SCOOTER, MODEL HS-235

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUPER SLIP FLOSSER

    FDA Adverse Event
    Injury ·RANIR, LLC·Product code JES·November 6, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 21, 2011

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 18, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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