BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    CARTO™ 3 EP Navigation System V8.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517632029·CoRoent Ant TLIF Ti, 15x12x30mm 12°

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124245·Modular Offset Stem 13mm x 100mm x 2mm

    Xenco Medical Cervical Interbody System (Argus)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 14, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 17, 2011

    UNKNOWN SOFRADIM MESH

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·July 23, 2013

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    FDA Enforcement
    Class II ·Ongoing·Bayer Medical Care, Inc.·June 10, 2026