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STRYKER ENDOSCOPY INC.

USA · San Jose

✓ 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

110listed device types

Class I 54Class II 56Class III 0

plus 247 registration records and 103 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

79registered devices

Class I 30Class II 49

101 including historic records

SASaudi ArabiaSFDA

90registered imported devices

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

CACanadaMDALL

37active device licences

Class II 32Class III 5

160 including historic records

TWTaiwanTFDA

30valid device licences

Class I 13Class II 17

SGSingaporeHSA SMDR

45device registrations

CLASS B 30CLASS C 14CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

137active ARTG entries

Class I 64Class III 3IIa 52IIb 15Class Is (sterile) 3

HKHong KongMDACS

6valid listings

Class II 5Class III 1

ILIsraelAMAR

27registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2a 5Class 2b 3

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 States247 registration records, 103 510(k), 0 PMA, 62 excluded

Brazil79 confirmed, 32 excluded

Saudi Arabia90 confirmed, 4 excluded

Canada37 confirmed, 7 excluded

Manufacturer names merged into this page: STRYKER ENDOSCOPY · Stryker Endoscopy · STRYKER ENDOSCOPY, A DIV. OF STRYKER CORP. DBA STRYKER ENDOSCOPY · STRYKER ENDOSCOPY INC.

FDA 510(k) clearances by year

22001

22002

82003

72004

32005

22006

42007

22008

12010

22012

32013

22014

32015

12016

22021

22022

32023

62024

52025

72026

FDA listed device types

showing 8 of 110

Electrosurgical, Cutting & Coagulation & Accessories 1Light, Surgical, Floor Standing 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) 1System, Irrigation, Urological 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262369	AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down	2026-07-30
US	DEN250040	SportSuite Vision Software	2026-07-17
US	K253602	Precision S 4K Sinuscope	2026-06-04
BR	80005430040	PINCAS PEEK DE APREENSÃO PARA CIRURGIAS ENDOSCÓPICAS STRYKER	Class I
BR	80005430584	CAMERA DE VIDEO CIRURGIA 1688 STRYKER	Class II
BR	80005430542	EQUIPOS PARA INSUFLADORES - ESTÉREIS	Class II
SA	ME0000009234SFDAA00001	EDAM for Berchtold Camera System	—
SA	ME0000005467SFDAA00307	Conquest Series™	—
CA	212	PATRIOT DISPOSABLE ARTHROSCOPY CANNULAS	Class II
CA	1529	HERMES CONTROL SYSTEM	Class II
CA	3848	QUADRACUT ACL SHAVER SYSTEM	Class II