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BIOSENSE WEBSTER, INC. - (IRVINE)

USA

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 0Class II 9Class III 4

plus 161 registration records and 76 510(k), 557 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

36 including historic records

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 2Class III 3Class IV 3

47 including historic records

TWTaiwanTFDA

15valid device licences

Class II 11Class III 4

SGSingaporeHSA SMDR

38device registrations

CLASS B 4CLASS C 1CLASS D 33

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

49active ARTG entries

Class I 2Class III 41IIa 2IIb 3Class Is (sterile) 1

HKHong KongMDACS

23valid listings

Class II 1Class III 2Class IV 20

ILIsraelAMAR

17registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 2Class 2a 1Class 2b 3Class 3 9

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States161 registration records, 76 510(k), 557 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: BIOSENSE WEBSTER, INC. · Biosense Webster (Israel), Ltd. · BIOSENSE WEBSTER INC. · BIOSENSE WEBSTER, A JOHNSON & JOHNSON COMPANY · BIOSENSE WEBSTER (ISRAEL) LTD. · BIOSENSE WEBSTER, INC. - (IRVINE)

Same-named companies — This database also contains companies with near-identical names: BIOSENSE WEBSTER INCORPORATED, BIOSENSE WEBSTER, A JOHNSON & JOHNSON COMPANY, Biosense Webster (Israel), Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42006

32007

12008

82009

42010

52011

22012

22013

32014

12016

22017

32018

12019

52020

12021

32022

62023

22024

12025

22026

FDA listed device types

showing 8 of 13

Ear, Nose, And Throat Stereotaxic Instrument 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Catheter, Flow Directed 1Electrode, Pacemaker, Temporary 1Catheter, Intracardiac Mapping, High-Density Array 1Catheter, Electrode Recording, Or Probe, Electrode Recording 1Computer, Diagnostic, Programmable 1Catheter, Ultrasound, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252972	CARTO 3 EP Navigation System V8.4	2026-02-20
US	K254085	CARTO 3 EP Navigation System V9.0 with PIU Plus	2026-01-18
US	K252302	CARTO 3 EP Navigation System V8.1	2025-08-22
BR	80145901999	CABOS DE INTERFACE BW	Class I
BR	80145909072	CONJUNTO DE TUBAGEM DE IRRIGAÇÃO SMARTABLATE	Class II
BR	80145909040	PATCHES DE REFERÊNCIA EXTERNA	Class I
SA	ME0000003191SFDAA00001	Interface Cable	—
SA	ME0000003191SFDAA00002	CARTO 3 system External Reference Patches	—
CA	9959	CARTO ELECTROPHYSIOLOGY MAPPING UNIT	Class IV
CA	61045	QWIKSTAR DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS	Class IV
CA	74557	EXCHANGE DILATOR	Class II