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Medtronic Surgical Navigation Technologies

USA · Louisville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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

25listed device types

Class I 6Class II 19Class III 0

plus 117 registration records and 88 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 6Class II 2

12 including historic records

SASaudi ArabiaSFDA

58registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

23active device licences

Class II 21Class III 2

65 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 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 States117 registration records, 88 510(k), 0 PMA, 7 excluded

Brazil8 confirmed, 0 excluded

Saudi Arabia58 confirmed, 0 excluded

Canada23 confirmed, 1 excluded

Manufacturer names merged into this page: MEDTRONIC NAVIGATION, INC. · MEDTRONIC NAVIGATION, INC. (Boxborough) · MEDTRONIC NAVIGATION ISRAEL LTD. · MEDTRONIC NAVIGATION, INC · MEDTRONIC NAVIGATION INC · Medtronic Navigation, Inc.

Same-named companies — This database also contains companies with near-identical names: MEDTRONIC NAVIGATION, INC., Medtronic Navigation Israel, Ltd., Medtronic Surgical Navigation. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42002

32003

42005

22006

12008

22010

32013

22014

22015

42016

52017

22018

32019

52020

32021

22022

12023

12024

32025

42026

FDA listed device types

showing 8 of 25

Electrosurgical, Cutting & Coagulation & Accessories 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Drape, Surgical, Exempt 1Neurological Stereotaxic Instrument 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Ear, Nose, And Throat Stereotaxic Instrument 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253379	Stealth AXiS Cranial clinical application	2026-03-26
US	K253395	Stealth AXiS ENT clinical application	2026-03-16
US	K253391	Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)	2026-03-13
BR	10349000667	Kit Universal de Instrumentais NavLock (9734833)	Class I
BR	10349001299	Kit de referência da coluna vertebral	Class I
BR	10349001300	Kit de pinos percutâneos	Class I
SA	ME0000000301SFDAA00278	Main Cart Stealth S8 EM ENT	—
SA	ME0000000301SFDAA00278	Main Cart Stealth S8 EM ENT	—
CA	27314	STEALTHSTATION ION FLUROSCOPIC NAVIGATION SYSTEM	Class III
CA	27825	STEALTHSTATION FAZER CONTOUR LASER	Class II
CA	60263	KNEE NAVIGATION SYSTEM	Class II

Medtronic Surgical Navigation Technologies

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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