BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    MONTAGE Settable, Resorbable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    EN SNARE

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011

    TEMPFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)

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

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 5, 2008

    TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

    FDA Adverse Event
    Malfunction ·CARIDIANBCT·Product code LKN·August 17, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 5, 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