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

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    BARD URETEROSCOPE DEFLECTION MODULE

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

    HUMAN IGM CSF KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 11, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·January 17, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·December 9, 2010

    ENDURITY DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    SMR REVERSE FINNED HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·February 4, 2022

    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