BEUDAMED
    93 results · 33ms · Sources: EU EUDAMED, US FDA

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    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (Tah-t) System

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CONCERTO CRT-D

    QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC.·Product code DRF·August 4, 2020

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·May 20, 2026

    QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 22, 2021

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 26, 2021

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 17, 2026

    SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·December 23, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·November 20, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·December 21, 2025

    SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·December 18, 2025

    QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·September 24, 2020

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·September 15, 2025

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·September 22, 2025

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·July 21, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·September 9, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 16, 2026

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 17, 2026

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·June 22, 2025