BIOSENSE WEBSTER, INC

FDA Filings

This page includes the latest FDA filings for BIOSENSE WEBSTER, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Biosense Webster, Inc.
CARTO 3 EP Navigation System, Version 7.1 And Accessories2019-07-20
Biosense Webster, Inc.
CARTO 3 EP Navigation System, Version 5.2 And Accessories With CARTOFINDER Module2018-08-24
Biosense Webster, Inc.
CARTO 3 EP Navigation System, Version 4.35 And Accessories With COHERENT MAP Module2018-06-14
Biosense Webster, Inc.
CARTO 3 EP Navigation System, Version 6.0 And Accessories With VISITAG SURPOINT2018-06-01
Biosense Webster, Inc.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath2017-07-25
Biosense Webster, Inc.
CARTO 3 EP Navigation System, Version 6.0 And Accessories2017-07-25
BIOSENSE WEBSTER
CARTO ENT System2016-10-24
BIOSENSE WEBSTER, INC.
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.22014-07-01
BIOSENSE WEBSTER
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER2014-03-12
BIOSENSE WEBSTER, INC.
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.22014-01-24
BIOSENSE WEBSTER, INC.
LASSO NAV DUO LOOP CATHETER2013-08-14
BIOSENSE WEBSTER, INC.
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER2013-03-05
BIOSENSE WEBSTER, INC.
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER2012-05-24
BIOSENSE WEBSTER, INC.
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)2012-05-07
BIOSENSE WEBSTER, INC.
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 22011-12-05
BIOSENSE WEBSTER, INC.
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER2011-11-18
BIOSENSE WEBSTER, INC.
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.22011-10-05
BIOSENSE WEBSTER, INC.
WEBSTER DUO-DECAPOLAR CATHETER2011-05-02
BIOSENSE WEBSTER, INC.
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)2011-01-21
BIOSENSE WEBSTER, INC.
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-122010-06-22
BIOSENSE WEBSTER, INC.
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,2010-06-22
BIOSENSE WEBSTER, INC.
Carto Xp Ep Navigation System, Version 102010-06-18
BIOSENSE WEBSTER, INC.
LASSO NAV CATHETER2010-06-18
BIOSENSE WEBSTER, INC.
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES2009-12-04
BIOSENSE WEBSTER, INC.
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-052009-12-04
BIOSENSE WEBSTER, INC.
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES2009-10-13
BIOSENSE WEBSTER, INC.
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER2009-09-04
BIOSENSE WEBSTER, INC.
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-122009-08-07
BIOSENSE WEBSTER, INC.
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-022009-01-06
BIOSENSE WEBSTER, INC.
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)2007-11-19

Latest Premarket Applications

PMAManufacturerDevice NameDate
BIOSENSE WEBSTER, INC.
Navistar DS Electrophysiology Catheter2020-02-26
BIOSENSE WEBSTER, INC.
Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology2020-02-26
BIOSENSE WEBSTER, INC.
Navistar Electrophysiology Catheter2020-02-26
Biosense Webster, Inc
Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog2020-02-26
BIOSENSE WEBSTER, INC.
EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter,2020-02-26
Biosense Webster, Inc
Celsius Catheter2019-08-02
BIOSENSE WEBSTER, INC.
EZ Steer Thermocool NAV Catheter and Navistar Thermocool2019-08-02
BIOSENSE WEBSTER, INC.
Celsius, EZ Steer, and Navistar Thermocool Catheter2019-08-02
BIOSENSE WEBSTER, INC.
CoolFlow Irrigation Tubing Set2019-05-08
BIOSENSE WEBSTER, INC.
SmartAblate Irrigation Pump, nGEN Pump s2019-04-29
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter2019-04-19
BIOSENSE WEBSTER, INC.
ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter2019-04-19
BIOSENSE WEBSTER, INC.
Vistag Surpoint External Process Unit (EPU)2019-04-02
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch Bi-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Navigation Catheter2019-03-26
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete2019-03-26
Biosense Webster, Inc
Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter2019-03-08
BIOSENSE WEBSTER, INC.
Navistar RMT Catheter2019-03-08
BIOSENSE WEBSTER, INC.
Navistar RMT Thermocool Catheter2019-03-08
BIOSENSE WEBSTER, INC.
Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool Catheter2019-03-08
BIOSENSE WEBSTER, INC.
THERMOCOOL SMARTTOUCH SF Uni/Bi-Directional Navigation Catheter2018-11-15
BIOSENSE WEBSTER, INC.
nGEN Pump2018-09-04
BIOSENSE WEBSTER, INC.
Navistar RMT Electrophysiology Catheter2018-07-30
BIOSENSE WEBSTER, INC.
Smartablate Cable2018-07-30
BIOSENSE WEBSTER, INC.
Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool2018-07-30
Biosense Webster, Inc
Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t2018-07-30
BIOSENSE WEBSTER, INC.
Celsius DS Electrophysiology Catheter2018-07-30
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch Uni-Bi-Directional Navigation Catheter2018-07-26
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch SF Catheters Uni/Bi-Directional Naviation Catheter2018-07-26
BIOSENSE WEBSTER, INC.
ThermoCool Smart Touch SF Bi-Directional Navigation Catheter & ThermoCool Smart Touch SF Uni-Direcional Navigation Cathe2018-07-18
BIOSENSE WEBSTER, INC.
SmartAblate System2018-06-15

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
CARTO 3
BIOSENSE WEBSTER (ISRAEL) LTD.2019-11-08
VIZIGO
BIOSENSE WEBSTER INC.2019-06-07
VIZIGO
BIOSENSE WEBSTER INC.2019-06-07
VIZIGO
BIOSENSE WEBSTER INC.2019-06-07
Reference Patch CARTO 3
BIOSENSE WEBSTER INC.2018-03-29

Related Finance Registrations
Legal Entity Identifier 549300UJX15XZCKL3C44 [BIOSENSE WEBSTER, INC.]

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