HomeCanadaSynaptive Medical, Inc.

Synaptive Medical, Inc.

Canada · Mississauga
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia — 5 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
7listed device types
Class I 2Class II 5Class III 0
plus 14 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 2IIa 3IIb 1
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 States14 registration records, 10 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Synaptive Medical Inc · SYNAPTIVE MEDICAL INC. · Synaptive Medical Inc.

Company information

Country
Canada
City
Mississauga

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

12014
12015
32016
12018
12019
12020
12023
12024

FDA listed device types

System, Image Processing, Radiological 1System, Nuclear Magnetic Resonance Imaging 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Neurological Stereotaxic Instrument 1System, X-Ray, Angiographic 1Microscope, Surgical 1Camera, Surgical And Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231986Modus IR2024-03-25
USK232981Synq Software Version 1.32023-10-11
USK200327Evry2020-04-29
SAME0000015925SFDAA00001Modus V™

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