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STRYKER IRELAND LIMITED

Ireland

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 3 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

69listed device types

Class I 19Class II 47Class III 2unclassified 1

plus 236 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States236 registration records, 2 510(k), 0 PMA, 55 excluded

Brazil3 confirmed, 22 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 20 excluded

Manufacturer names merged into this page: STRYKER IRELAND OSTEONICS · STRYKER IRELAND LTD., INSTRUMENTS DIVISION · Stryker Ireland Ltd. Instruments Division, Innovation Centre · HOWMEDICA OSTEONICS STRYKER IRELAND · STRYKER IRELAND LIMITED · STRYKER IRELAND LTD

FDA 510(k) clearances by year

22008 · K082010

FDA listed device types

showing 8 of 69

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Thoracolumbosacral Pedicle Screw System 1Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K082010	STRYKER DISPOSABLE CRANIAL PERFORATOR BIT	2008-12-29
US	K073633	STRYKER ESSX MICRODEBRIDER SYSTEM	2008-08-26
BR	80005430048	PINÇAS CONQUEST DE APRENSAO PARA CIRURGIAS ARTROSCOPICAS STRYKER	Class II
BR	80005430196	INSTRUMENTAL PARA CIRURGIA DE JOELHO	Class II
BR	80005430279	PROVA DE INSTRUMENTAL EM COPOLÍMERO ACETAL PARA CIRURGIA DE JOELHO	Class I

STRYKER IRELAND LIMITED

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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