BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    Immunoglobulin G (IgG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004000·Luna Opal MB Mini .022 LR3 (-6°T +3°A)

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705007479·Flat Washer 14mm

    TO BE ASSIGNED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033539897·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690130000·Retaining Bolt, PS or PS-C Insert, Revision Tib...

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221114070·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221114000·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221114150·

    TIGRAN PERIBRUSH

    FDA 510(k)
    FDA Class 2 ·Dental

    'RAPIDTEC' 5A MULTIPLE DIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149278·Straight Implant Trial 22mm x 11mm x 14mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523134106·Tesera ST, 22mm X 11mm X 14mm, Convex, T3

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·July 17, 2024

    BD ANGIOCATH AUTOGAURD IV CATHETER

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·May 19, 2009

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·November 3, 2014

    URETEX SUP URETRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 8, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 24, 2015

    Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023