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MICROSURGICAL TECHNOLOGY, INC.

USA · Redmond

✓ Record-verifiedregistrations found in 8 markets

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

35listed device types

Class I 25Class II 10Class III 0

plus 36 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 2Class II 19

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

1active device licences

Class II 1

20 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

15active ARTG entries

Class I 6IIa 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States36 registration records, 10 510(k), 0 PMA, 7 excluded

Brazil21 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MICROSURGICAL TECHNOLOGY, INC. · MICROSURGICAL TECHNOLOGY INC. · MICROSURGICAL TECHNOLOGY INC

FDA 510(k) clearances by year

11984

31985 · K854402

31994 · K943672

21995 · K953959

12022 · K213173

FDA listed device types

showing 8 of 35

Hook, Ophthalmic 1Marker, Ocular 1Perimeter, Manual 1Scissors, Ophthalmic 1Cystotome 1Chart, Visual Acuity 1Cannula, Ophthalmic 1Punch, Corneo-Scleral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213173	TrabEx Pro	2022-06-08
US	K953959	PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES	1995-11-17
US	K946194	WEE BAG O'MERCURY	1995-02-27
BR	81346509079	Bisturi Oftálmico Accusharp - Com Capa	Class II
BR	81346509080	Bisturi Oftálmico Accusharp	Class II
BR	81346509081	TrabEx	Class II
CA	74593	STAINLESS STEEL STERILE KNIVES	Class II

MICROSURGICAL TECHNOLOGY, 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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