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Key Surgical, Inc.

USA · Eden Prairie

✓ Record-verifiedregistrations found in 8 markets

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

27listed device types

Class I 20Class II 7Class III 0

plus 30 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

52registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

27active ARTG entries

Class I 24IIa 3

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

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 States30 registration records, 6 510(k), 0 PMA, 16 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia52 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Key Surgical, LLC · KEY SURGICAL, LLC · KEY SURGICAL LLC

FDA 510(k) clearances by year

21989 · K896472

11990 · K896676

11991 · K910328

22015 · K150532

FDA listed device types

showing 8 of 27

Electrosurgical, Cutting & Coagulation & Accessories 1Indicator, Physical/Chemical Sterilization Process 1Pin, Fixation, Smooth 1Wrap, Sterilization 1Plate, Fixation, Bone 1Anti Fog Solution And Accessories, Endoscopy 1Screw, Fixation, Bone 1Marker, Skin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150532	Universal Light Handle Cover, Light Handle Cover	2015-09-22
US	K151222	Cautery Tip Cleaner	2015-05-22
US	K910328	KEY COMFORT GRIPS	1991-03-06
SA	ME0000007347SFDAA00013	CLEANER	—
SA	ME0000007347SFDAA00009	CLEANING BRUSH	—

Key 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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