BEUDAMED
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    JLK-PWI

    FDA UDI
    JLK, Inc.·08800066200794·

    JLK-PWI

    FDA 510(k)
    FDA Class 2 ·Radiology

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 1, 2023

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 13, 2022

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·September 19, 2023

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2022

    UNK_SMART TOUCH BIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 1, 2021

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 1, 2021

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·July 16, 2024

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 16, 2022

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·August 26, 2020

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code OAE·September 24, 2025

    BIVONA

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·September 2, 2020

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 16, 2014

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 19, 2014

    FARAWAVE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·November 19, 2024

    SWARTZ¿ INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code DYB·September 24, 2025

    FARAWAVE PULSED FIELD ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·September 16, 2024

    FARAWAVE NAV

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·March 20, 2026

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·December 5, 2024