HomeUSAMEDTRONIC NEUROMODULATION

MEDTRONIC NEUROMODULATION

USA · Minneapolis
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Singapore — 3 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
26listed device types
Class I 5Class II 6Class III 11unclassified 4
plus 29 registration records and 1 510(k), 1,418 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
4valid device licences
Class II 1Class III 3
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
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 States29 registration records, 1 510(k), 1,418 PMA, 8 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: MEDTRONIC NEUROMODULATION

Company information

Country
USA
City
Minneapolis

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

12021 · DEN210003

FDA listed device types

showing 8 of 26
Stimulator, Thalamic, Epilepsy, Implanted 1Stimulator, Electrical, Implantable, For Incontinence 1Stimulator, Electrical, Implanted, For Essential Tremor 1Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 1Stimulator, Electrical, Implanted, For Parkinsonian Tremor 1Deep Brain Stimulation For The Treatment Of Dystonia 1Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy 1Implanted Electrical Device Intended For Treatment Of Fecal Incontinence 1

Registration details (sample)

MarketIdentifierNameClass / date
USDEN210003SureTune4 Software2021-08-23

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