BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    PRIMA Humeral System; PRIMA TT Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITA TITANKERAMIK

    FDA UDI
    Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2337120·VITA TITANKERAMIK OPAQUE DENTINE, 2M3, 12 g

    MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMBRYOVIEWER SOFTWARE

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

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 9, 2019

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 5, 2018

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIPMENT CO.·Product code ITI·November 18, 2015

    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