BEUDAMED
    71 results · 32ms · Sources: EU EUDAMED, US FDA

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    Volta AF-Xplorer

    FDA UDI
    SUBSTRATE HD·03770019196038·Cardiac Electrophysiology mapping tool

    VX1

    FDA UDI
    SUBSTRATE HD·03770019196007·Cardiac Electrophysiology mapping tool

    Volta AF-Xplorer II

    FDA UDI
    SUBSTRATE HD·03770019196069·Cardiac Electrophysiology mapping tool

    THERMOCOOL SMARTTOUCH

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2024

    AGILIS NXT INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·January 5, 2025

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·February 4, 2022

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·January 5, 2025

    UNK_PENTARAY NAV

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code MTD·October 5, 2021

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 5, 2021

    SWARTZ¿ INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·September 29, 2022

    AGILIS NXT INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·September 29, 2022

    HD CAMERA HEAD

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·January 11, 2023

    BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 10, 2017

    TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER

    FDA Adverse Event
    Death ·VENUSA DE MEXICO S.A. DE C.V.·Product code OAE·August 17, 2021

    TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER

    FDA Adverse Event
    Injury ·VENUSA DE MEXICO S.A. DE C.V.·Product code OAE·August 17, 2021

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code DRF·June 10, 2025

    VISERA ELITE II VIDEO SYSTEM CENTER

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·October 31, 2020

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 5, 2021

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code LPB·October 5, 2021

    UNK_PENTARAY NAV

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code MTD·October 5, 2021