BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    Self-adhesive Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GN OTOMETRICS INSERT EARPHONES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    QUADRA-P FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

    OPAL 10*28 H11 REVOLVABLE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MAX·June 21, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 22, 2011

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·September 23, 2008

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025

    STIMULATION/DISSECTION INSTRUMENTS

    FDA Adverse Event
    Malfunction ·NUVASIVE, INCORPORATED·Product code ETN·October 29, 2022

    OT VERIO SYNC METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 12, 2013

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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