HomeIrelandStryker Ireland Ltd. Instruments Division, Innovation Centre

Stryker Ireland Ltd. Instruments Division, Innovation Centre

Ireland · Carrigtwohill Cork
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
27listed device types
Class I 11Class II 15Class III 0unclassified 1
plus 43 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
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 States43 registration records, 1 510(k), 0 PMA, 15 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 8 excluded
Manufacturer names merged into this page: Stryker Ireland Ltd. Instruments Division, Innovation Centre

Company information

Country
Ireland
City
Carrigtwohill Cork

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12026 · K261410

FDA listed device types

showing 8 of 27
Electrosurgical, Cutting & Coagulation & Accessories 1Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Motor, Drill, Pneumatic 1Trap, Sterile Specimen 1Bone Cement, Posterior Screw Augmentation 1Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision 1Pin, Fixation, Smooth 1Thoracolumbosacral Pedicle Screw System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30

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