1,338 results · 32ms · Sources: EU EUDAMED, US FDA

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SIMILAR DEVICE BNI75TCDDH, PMA # P030031

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 2, 2017

SIMILAR DEVICE DI7TCBLRT, PMA # P030031

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·February 9, 2015

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·January 14, 2014

THERMOCOOL® SMART TOUCH?

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAE·February 14, 2014

THERMOCOOL SMARTTOUCH SF

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 2, 2025

THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER P030031/S053

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·April 18, 2018

THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·August 25, 2014

THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·April 5, 2016

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·VISITAG SURPOINT External Processing Unit (EPU)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CELSIUS THERMOCOOL CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Thermocool Smarttouch SF

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter