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Stryker Instruments, Instruments Div.

USA · Kalamazoo

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 191 registration records and 80 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 3Class II 13

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

193registered imported devices

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

CACanadaMDALL

40active device licences

Class II 34Class III 6

163 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States191 registration records, 80 510(k), 0 PMA, 77 excluded

Brazil16 confirmed, 23 excluded

Saudi Arabia193 confirmed, 9 excluded

Canada40 confirmed, 14 excluded

Manufacturer names merged into this page: Stryker Instruments · STRYKER ENDOSCOPY, A DIV. OF STRYKER CORP. DBA STRYKER ENDOSCOPY · STRYKER CORP., MEDICAL DIV. · STRYKER INSTRUMENTS

FDA 510(k) clearances by year

51999

32000

72001

42002

92003

42004

62005

42006

32007

12008

12010

12012

12013

12017

12021

22022

12023

42024

82025

32026

FDA listed device types

showing 8 of 101

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Thoracolumbosacral Pedicle Screw System 1Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Bottle, Collection, Vacuum 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Hood, Surgical 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	80005430220	GORRO FLYTE	Class I
BR	80005439050	bonevac	Class II
BR	80005430228	RECIPIENTE DE ASPIRAÇÃO PARA SONOPET	Class I
SA	ME0000009223SFDAA00001	Stryker System G™ Sterilization Case	—
SA	ME0000003208SFDAA00387	System 6™	—
CA	212	PATRIOT DISPOSABLE ARTHROSCOPY CANNULAS	Class II
CA	1529	HERMES CONTROL SYSTEM	Class II
CA	3848	QUADRACUT ACL SHAVER SYSTEM	Class II

Stryker Instruments, Instruments Div.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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