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MIZUHO ORTHOPEDIC SYSTEMS, INC.

USA · Union City

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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

20listed device types

Class I 17Class II 3Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

122registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States21 registration records, 0 510(k), 0 PMA, 7 excluded

Brazil3 confirmed, 2 excluded

Saudi Arabia122 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: MIZUHO ORTHOPEDIC SYSTEMS, INC. · Mizuho Orthopedic Systems, Inc · MIZUHO ORTHOPEDIC SYSTEMS, INC · Mizuho Orthopedic Systems Inc

FDA listed device types

showing 8 of 20

Splint, Traction 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1Protector, Skin Pressure 1Halter, Head, Traction 1Stand, Infusion 1Support, Patient Position 1Restraint, Protective 1Sling, Arm 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80047300866	Mesa Cirúrgica Ortopédica - Hana	Class I
BR	80047300867	Sistema de Mesa Cirúrgica - Trios	Class I
BR	80047300870	Mesa de Cicurgia espinhal - ProAxis	Class I
SA	ME0000009400SFDAA00002	Pkit, STS 7IN, GT II POLLOW, SG,CVR ARM6/CS	—
SA	ME0000009400SFDAA00004	PERINEAL POST, AUDL W/PAD	—

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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