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