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Boston Scientific Corporation -

USA · Marlborough

✓ 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

227listed device types

Class I 36Class II 142Class III 47unclassified 2

plus 1,872 registration records and 871 510(k), 6,772 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

153registered devices

Class I 16Class II 137

638 including historic records

SASaudi ArabiaSFDA

21registered imported devices

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

CACanadaMDALL

490active device licences

Class II 198Class III 54Class IV 238

1,197 including historic records

TWTaiwanTFDA

138valid device licences

Class I 10Class II 108Class III 20

SGSingaporeHSA SMDR

270device registrations

CLASS B 97CLASS C 75CLASS D 90D WITH MEDICINAL PRODUCT 8

KRSouth KoreaMFDS GMP

19GMP quality-system certificates

Import 19

AUAustraliaTGA ARTG

316active ARTG entries

Class I 30Class III 124IIa 82IIb 57Class Im (measuring) 1Class Is (sterile) 22

HKHong KongMDACS

176valid listings

Class II 72Class III 39Class IV 65

ILIsraelAMAR

281registrations

RURussiaRoszdravnadzor

180active registrations

Class 1 2Class 2a 33Class 2b 54Class 3 91

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.

Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States1,872 registration records, 871 510(k), 6,772 PMA, 29 excluded

Brazil153 confirmed, 4 excluded

Saudi Arabia21 confirmed, 0 excluded

Canada490 confirmed, 4 excluded

Manufacturer names merged into this page: Boston Scientific Corporation · Boston Scientific Limited · BOSTON SCIENTIFIC CORPORATION · Boston Scientific Corp., Marina Bay Cust. Fulfillment Center · BOSTON SCIENTIFIC IRELAND LTD. · INTERVENTIONAL TECHNOLOGIES EUROPE LTD. A SUB. OF BOSTON SCIENTIFIC

FDA 510(k) clearances by year

92007

122008

152009

132010

262011

282012

212013

342014

262015

162016

252017

172018

232019

212020

202021

172022

262023

162024

172025

132026

FDA listed device types

showing 8 of 227

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Catheter, Intracardiac Mapping, High-Density Array 1Lithotriptor, Biliary Mechanical 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling 1Probe, Radiofrequency Lesion 1Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262406	EluPro Antibiotic-Eluting BioEnvelope	2026-08-12
US	K262165	FARADRIVE Steerable Sheath (M004PF21M402)	2026-07-24
US	K262462	TheraSphere 360 Y-90 Management Platform	2026-07-24
BR	10341350264	ZERO TIP CESTO PARA RECUPERACAO DE CALCULOS	Class II
BR	10341350464	JAGWIRE	Class II
BR	10341350302	TANDEM CÂNULA DE LÚMEN TRIPLO PARA CPER	Class I
CA	385	NIR STENT	Class IV
CA	823	NIROYAL PREMOUNTED STENT SYSTEM	Class IV
CA	826	NIROYAL STENT	Class IV