BEUDAMED
    8 results · 18ms · 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.

    QUADRAPLEGIC WALKING AID

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TOTAL HIP SURGETICS NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    IRENE Thoracolumbar Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·January 2, 2025

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON SARL A JOHNSON & JOHNSON COMPANY·Product code FTL·October 4, 2012

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 19, 2013

    UNK DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·July 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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