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Boston Scientific Neuromodulation Corporation

USA · Valencia

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

10listed device types

Class I 0Class II 4Class III 6

plus 15 registration records and 10 510(k), 34 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

25 including historic records

TWTaiwanTFDA

3valid device licences

Class II 1Class III 2

SGSingaporeHSA SMDR

21device registrations

CLASS C 3CLASS D 18

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

100active ARTG entries

Class I 9Class III 69IIa 9IIb 10Class Is (sterile) 3

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

13active registrations

Class 2b 3Class 3 10

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 States15 registration records, 10 510(k), 34 PMA, 7 excluded

Brazil3 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Boston Scientific Neuromodulation Corporation · BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

FDA 510(k) clearances by year

32019 · K190960

22020 · K202274

12021 · K203547

12022 · K221376

22024 · K233801

12025 · K251247

FDA listed device types

showing 8 of 10

Probe, Radiofrequency Lesion 1Stimulator, Spinal-Cord, Implanted (Pain Relief) 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Generator, Lesion, Radiofrequency 1Stimulator, Electrical, Implanted, For Essential Tremor 1Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 1Stimulator, Electrical, Implanted, For Parkinsonian Tremor 1Prosthesis, Spinous Process Spacer/Plate 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251247	GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)	2025-08-07
US	K233801	Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation	2024-08-23
US	K232415	Nalu Neurostimulation System for Peripheral Nerve Stimulation	2024-08-21
BR	80528190010	CÂNULAS DESCARTÁVEIS SILICONIZADAS PARA GERADOR DE RADIOFREQUÊNCIA DE	Class II
BR	80528190051	CÂNULAS UNIFICADAS DESCARTÁVEIS PARA NEUROMODULAÇÃO EM GERADOR DE RF D	Class II
BR	80528199006	Cânulas Expansivas Sidekick 2 para Gerador de 4 Canais	Class II

Boston Scientific Neuromodulation Corporation

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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