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

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    UNIQUE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ThermoCool SmartTouch

    FDA UDI
    Biosense Webster Inc·10846835009200·

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 1, 2016

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 1, 2016

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 1, 2016

    ARMADA 14 PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISTAL RADIUS FRACTURE REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMOCOOL SMARTTOUCH

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·February 1, 2021

    BIOSENSE WEBSTER THERMOCOOL

    FDA Adverse Event
    Malfunction ·BIOSENSE·Product code LPB·June 20, 2017

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 14, 2017

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code LPB·July 6, 2017

    THERMOCOOL SMARTTOUCH

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC.·Product code DRF·October 6, 2016

    SMARTABLATE¿ IRRIGATION PUMP

    FDA Adverse Event
    Injury ·STOCKERT GMBH·Product code LPB·September 16, 2015

    THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·August 28, 2020

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·November 10, 2014

    THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·March 18, 2021

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code OAD·July 6, 2017

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 5, 2014