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Vortex Surgical, Inc.

USA · Saint Charles

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 8 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

13listed device types

Class I 7Class II 6Class III 0

plus 12 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States12 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil10 confirmed, 1 excluded

Manufacturer names merged into this page: Vortex Surgical, Inc. · VORTEX SURGICAL INC.

FDA 510(k) clearances by year

12019 · K191846

12022 · K220263

FDA listed device types

showing 8 of 13

Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal 1Kit, Surgical Instrument, Disposable 1Cannula, Ophthalmic 1Hook, Ophthalmic 1Depressor, Orbital 1Marker, Sclera 1Forceps, Ophthalmic 1Transilluminator, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220263	Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers	2022-11-03
US	K191846	MAXReach Laser Probe	2019-12-23
BR	81346509038	Cânula de Aspiração e Irrigação Poli-imida Vortex	Class II
BR	81346509039	Cânula de Aspiração e Irrigação Nitinol Vortex	Class II
BR	81346509041	Cânula de Aspiração e Irrigação Poliuretano Vortex	Class II

Vortex Surgical, 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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