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

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    Anivia SG1000 Pump Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Neodent Implant System - Zirconia Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    HISPEED DUAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 7, 2008

    2242816-2011-00501

    FDA Adverse Event
    Injury ·EBI, LLC·August 24, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 3, 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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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