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HYDROCISION, INC.

USA · Billerica

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 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

2listed device types

Class I 1Class II 1Class III 0

plus 5 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

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

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States5 registration records, 12 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: HYDROCISION, INC. · HYDROCISION INC. · HYDROCISION, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241990	SpineSite Endoscope System	2025-07-30
US	K200729	HydroCision SpineJet System	2020-04-16
US	K190804	HydroCision TenJet Device	2019-06-05
BR	10355870121	KIT CÂNULA DESCARTÁVEL CURVO SPINEJET	Class II
BR	10355870039	KIT CANULA PARA DISCECTOMIA SPINEJET	Class II
BR	10355870036	CONSOLE SPINEJET	Class II

HYDROCISION, INC.

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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