FDA.reportPublic FDA data

BIOSENSE WEBSTER, INC.

Matched from indexed company URL: Biosense Webster Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96732413003248396BIOSENSE WEBSTER, INC.1N2026-01-01CIRCUITO INTERIOR NORTE, No. 1820 PARQUE INDUSTRIAL SALVARCAR JUAREZ Chihuahua MX 32574
30082030033008203003Biosense Webster (Israel), Ltd.1N2026-01-014 Hatnufa Street Yokneam Northern IL 2066717
30133000263013300026BIOSENSE WEBSTER, INC.1Y2026-01-0131 Technology Drive, Suite 200 -- Irvine CA US 92618
30224510733022451073BIOSENSE WEBSTER, INC.1N2026-01-0123 Hubble Drive Irvine CA US 92618
20206382020638BIOSENSE WEBSTER, INC.1Y2020-04-255110 COMMERCE RD. BALDWIN PARK CA US 91706
20290463003113629BIOSENSE WEBSTER, INC.1Y2020-04-2515715 ARROW HWY. IRWINDALE CA US 91706

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10846835009798THERMOCOOL SMARTTOUCH SF - D134703+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
587421452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587431452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587451452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
3083481452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587421419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587431419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587451419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
3083481419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587421559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
587431559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
587451559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
3083481559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
587451163060217P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)QZI2024-11-06
3083481163060217P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)QZI2024-11-06
587451316897506P210027QDOT MICRO™ SystemOAE2022-11-23
3083481316897506P210027QDOT MICRO™ SystemOAE2022-11-23
587421165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587431165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587451165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
3083481165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587421612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587431612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587451612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
3083481612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587421366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587431366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587451366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
3083481366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587421148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587431148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587451148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
3083481148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587421367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587431367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587451367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
3083481367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587431780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
587451780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
3083481780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
587421063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587431063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587451063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
3083481063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587421078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587431078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587451078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
3083481078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587421942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
587431942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
587451942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
3083481942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
587421425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587431425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587451425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
3083481425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587421816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587431816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587451816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
3083481816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587421079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587431079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587451079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
3083481079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587421700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
587431700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
587451700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
3083481700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
587421306939737K892265
587431306939737K892265
587451306939737K892265
3083481306939737K892265
587421718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587431718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587451718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
3083481718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587421373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587431373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587451373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587421836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
587431836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
587451836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
3083481836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
1128591526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
3083481526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
1128591196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3083481196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3140191196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
1128591889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3083481889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3140191889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
587451999568673K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28
3083481999568673K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28
3083482045780395K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterOBJ2024-06-12
587451570366164K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDMTD2023-07-10
3083481570366164K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDMTD2023-07-10
1128591259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3083481259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3140191259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
587451838273211K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02
3083481838273211K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02
587452007244677K223766NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16
3083482007244677K223766NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF1222022-01-26
DQK562026-02-20
MTD222023-07-10
OBJ202024-06-28
DYB152017-07-25
LPB142006-08-11
OAD102004-11-05
DSA52000-07-21
DYG51985-12-03
LDF41984-10-18
PGW12016-10-24

PMA#

QDOT MICRO™ System

2022-11-23

Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE  Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No

Biosense Webster Cables

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS056 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

Celsius FLTRR, EZ Steer Nav DS Catheter

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

NAVISTAR

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

CELSIUS

2022-09-09

Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS084 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reas...

8mm Dual Sensor (DS) Catheters

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

SmartAblate Irrigation Tubing Set and nGEN Pump

2022-06-08

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

SmartAblate Irrigation Tubing Set

2022-03-15

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

200 records. Showing 1-40. Next

PMN#

73 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next