HomeIrelandSTRYKER IRELAND OSTEONICS

STRYKER IRELAND OSTEONICS

Ireland · Cork Cork
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
43listed device types
Class I 9Class II 32Class III 2
plus 162 registration records and 49 510(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
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 States162 registration records, 49 510(k), 0 PMA, 5 excluded
Brazil3 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: STRYKER IRELAND OSTEONICS · HOWMEDICA OSTEONICS – STRYKER IRELAND · HOWMEDICA OSTEONICS CORP./STRYKER ORTHOPAEDICS
Same-named companies — This database also contains companies with near-identical names: Stryker Osteonics. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Ireland
City
Cork 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

11998
12006
22010
32011
22012
12016
22017
12018
42019
42020
32021
52022
62023
52024
62025
32026

FDA listed device types

showing 8 of 43
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Cement Obturator 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
USK261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component2026-07-10
USK253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert2026-02-18
BR80005430048PINÇAS CONQUEST DE APRENSAO PARA CIRURGIAS ARTROSCOPICAS STRYKERClass II
BR80005430296KIT INSTRUMENTAL NÃO ESTÉRIL PARA QUADRILClass I
BR80005430345Cateter de Balão iVASClass II

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