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OMEGA SURGICAL INSTRUMENTS, INC.

USA · Grand Blanc

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 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

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

4active device licences

Class II 4

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States4 registration records, 3 510(k), 0 PMA, 29 excluded

Brazil7 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada4 confirmed, 4 excluded

Manufacturer names merged into this page: OMEGA SURGICAL INSTRUMENTS, INC. · OMEGA SURGICAL INSTRUMENTS,INC · Omega Surgical Instruments, Inc · OMEGA SURGICAL INSTRUMENTS, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K941434	K-WIRES AND STEINMANN PINS	1994-10-03
US	K933595	BUR, SURGICAL, GENERAL & PLASTIC SURGERY	1994-03-16
US	K933298	SAW BLADE	1993-08-09
BR	80286279001	BROCAS CIRÚRGICAS ESTÉREIS DE AÇO INOXIDÁVEL REVESTIDAS DE DIAMANTE OM	Class II
BR	80286279002	BROCAS CIRÚRGICAS ESTÉREIS DE CARBONETO OMEGA	Class II
BR	80286279003	BROCAS CIRÚRGICAS ESTÉREIS DE AÇO INOXIDÁVEL COM NITRETO DE TITÂNIO OM	Class II
CA	6795	OMEGA BURS (DIAMOND)	Class II
CA	6804	OMEGA BURS (CARBIDE)	Class II
CA	6841	OMEGA BLADES	Class II

OMEGA SURGICAL INSTRUMENTS, 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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