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

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    EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Synergy

    FDA UDI
    Rmo, Inc.·00885797100924·BRACHY SY 185 HK MX/3 5-5 20EA

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046536·NTS Standard Tube, 22x70mm

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM

    MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERASPHERE Y-90 (5 GBQ)

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 26, 2023

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·August 11, 2011

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·June 28, 2013

    MESH-COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 17, 2014

    EVIS EXERA II DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·January 5, 2024

    LIGASURE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·June 7, 2022

    NOVAFLEX+ DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 5, 2022

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·January 19, 2023

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·June 7, 2022

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·September 14, 2022

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·September 14, 2022

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·January 19, 2023

    O-ARM IMAGING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·December 19, 2022