HomeIsraelMazor Robotics , Ltd.

Mazor Robotics , Ltd.

Israel · Caesarea
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
3listed device types
Class I 0Class II 3Class III 0
plus 7 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
12active ARTG entries
Class I 4IIa 7IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
9registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 States7 registration records, 13 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: MAZOR ROBOTICS LTD.

Company information

Country
Israel
City
Caesarea

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
12012
12014
12015
22017
22018
22020
12023
12025

FDA listed device types

Orthopedic Stereotaxic Instrument 1System, Image Processing, Radiological 1Neurological Stereotaxic Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251316Mazor X System / Mazor X Stealth Edition2025-09-11
USK230064Mazor X System (Mazor X Stealth Edition)2023-04-07
USK203005Mazor X2020-10-27

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