HomeUSAStryker Neurovascular

Stryker Neurovascular

USA · Fremont
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
17listed device types
Class I 1Class II 13Class III 2unclassified 1
plus 114 registration records and 33 510(k), 38 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
34 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
43 including historic records
TWTaiwanTFDA
15valid device licences
Class II 11Class III 4
SGSingaporeHSA SMDR
25device registrations
CLASS B 2CLASS D 23
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
36active ARTG entries
Class III 32IIa 2Class Is (sterile) 2
HKHong KongMDACS
23valid listings
Class II 1Class IV 22
ILIsraelAMAR
26registrations
RURussiaRoszdravnadzor
4active registrations
Class 3 4
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 States114 registration records, 33 510(k), 38 PMA, 18 excluded
Brazil0 confirmed, 3 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: Stryker Neurovascular · STRYKER NEUROVASCULAR

Company information

Country
USA
City
Fremont

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

22011
32012
22013
12014
32016
12017
42019
32020
42021
12022
12023
22024
42025
22026

FDA listed device types

showing 8 of 17
Catheter, Continuous Flush 1Guide, Wire, Catheter, Neurovasculature 1Wire, Guide, Catheter 1Catheter, Intravascular, Diagnostic 1Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment 1Catheter, Thrombus Retriever 1Catheter, Percutaneous, Neurovasculature 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261889Trevo Trak 21 Microcatheter2026-07-01
USK253032AXS Lift Intracranial Base Catheter2026-02-11
USK252694Target Detachable Coil2025-12-11
CA78101DAC (DISTAL ACCESS CATHETER)Class II
CA91316TRACKER-17 MICROCATHETERClass II

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