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Stryker Instruments

USA · Portage

✓ 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

101listed device types

Class I 51Class II 49Class III 0unclassified 1

plus 265 registration records and 82 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

55registered devices

Class I 9Class II 46

63 including historic records

SASaudi ArabiaSFDA

195registered imported devices

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

CACanadaMDALL

38active device licences

Class II 33Class III 5

173 including historic records

TWTaiwanTFDA

9valid device licences

Class I 5Class II 4

SGSingaporeHSA SMDR

44device registrations

CLASS B 31CLASS C 10CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

129active ARTG entries

Class I 36Class III 1IIa 61IIb 15Class Im (measuring) 1Class Is (sterile) 15

HKHong KongMDACS

8valid listings

Class II 6Class III 1Class IV 1

ILIsraelAMAR

26registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

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 States265 registration records, 82 510(k), 0 PMA, 74 excluded

Brazil55 confirmed, 22 excluded

Saudi Arabia195 confirmed, 8 excluded

Canada38 confirmed, 14 excluded

Manufacturer names merged into this page: STRYKER IRELAND LTD., INSTRUMENTS DIVISION · Stryker Ireland Ltd. Instruments Division, Innovation Centre · Stryker Instruments · STRYKER INSTRUMENTS A DIVISION OF STRYKER CORPORATION · STRYKER INSTRUMENTS, A DIVISION OF STRYKER CORPORATION · STRYKER INSTRUMENTS (PORTAGE)

FDA 510(k) clearances by year

51999

32000

72001

42002

92003

42004

62005

42006

32007

32008

12010

12012

12013

12017

12021

22022

12023

42024

82025

32026

FDA listed device types

showing 8 of 101

Instrument, Ultrasonic Surgical 1Motor, Surgical Instrument, Ac-Powered 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Instrument, Ent Manual Surgical 1Container, Specimen, Sterile 1Unit, Operative Dental 1Brush, Dermabrasion, Powered 1Spinal Channeling Instrument, Vertebroplasty 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261544	Hydro Irrigation System	2026-06-17
US	K253679	Hydro Irrigation System	2026-05-08
US	K252282	SurgiCount+ System	2026-03-16
BR	80005430218	RECIPIENTE COM LAMINA PARA BONE MILL	Class I
BR	80005430221	VESTIMENTA FLYTE	Class I
BR	80005430320	CAPACETES STRYKER	Class I
SA	ME0000009223SFDAA00001	Stryker System G™ Sterilization Case	—
SA	ME0000003208SFDAA00387	System 6™	—
CA	1233	DISCOGRAPHY SYSTEM	Class II
CA	1234	SURGICAL DYNAMICS NUCLEOTOME SYSTEM	Class II
CA	4126	CRS CEMENT REMOVAL SYSTEM	Class II