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STRYKER MEDICAL

USA · Portage

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel, Russia — 9 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

51listed device types

Class I 19Class II 32Class III 0

plus 63 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

30registered devices

Class I 29Class II 1

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

SASaudi ArabiaSFDA

26registered imported devices

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

CACanadaMDALL

16active device licences

Class II 15Class III 1

29 including historic records

TWTaiwanTFDA

11valid device licences

Class I 10Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

43active ARTG entries

Class I 34IIa 2IIb 2Class Im (measuring) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 3Class 2a 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 States63 registration records, 20 510(k), 0 PMA, 72 excluded

Brazil30 confirmed, 21 excluded

Saudi Arabia26 confirmed, 9 excluded

Canada16 confirmed, 14 excluded

Manufacturer names merged into this page: STRYKER MEDICAL · Stryker (Suzhou) Medical Technology Co.,Ltd. · Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. · Stryker Trauson (Changzhou) Medical Technology Co., Ltd. · STRYKER CORP., MEDICAL DIV. · STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO., LTD

FDA 510(k) clearances by year

11991

21992

51994

11995

12011

12016

12017

12018

12019

12023

12024

32025

12026

FDA listed device types

showing 8 of 51

Stretcher, Hand-Carried 1Cushion, Flotation 1Stool, Operating-Room 1Mattress, Flotation Therapy, Non-Powered 1Clamp 1Chair, Examination And Treatment 1Guide, Surgical, Instrument 1Bed, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253159	Prophecy Incompass Surgical Planning System	2026-06-16
US	K251643	Synchfix EVT	2025-10-29
US	K252085	Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)	2025-09-30
BR	80005439001	MACA HOSPITALAR STRYKER	Class I
BR	80005430588	MACA PERFORMANCE-PRO XT STRYKER	Class I
BR	80005430393	MACAS PARA TRANSPORTE PRIME MANUAIS	Class I
SA	ME0000000992SFDAA00184	fFoam Mattress	—
SA	ME0000001368SFDAA00002	Foam Mattress	—
CA	2947	DYNAMIC MATTRESS SYSTEM (DMS 2500)	Class II
CA	3266	CIRCO-LECTRIC BED	Class II
CA	12559	INFANT WARMER	Class III

STRYKER MEDICAL

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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