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MIZUHO AMERICA, INC.

USA · Union City

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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 13Class II 0Class III 0

plus 13 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 7Class II 1

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

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States13 registration records, 5 510(k), 0 PMA, 6 excluded

Brazil8 confirmed, 2 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MIZUHO AMERICA, INC. · MIZUHO AMERICA INC.

FDA 510(k) clearances by year

11996 · K955012

11997 · K960037

11999 · K990202

22022 · K221524

FDA listed device types

showing 8 of 13

Instrument, Cutting, Orthopedic 1Forceps 1Scissors, General, Surgical 1Retractor 1Dissector, Surgical, General & Plastic Surgery 1Handle, Scalpel 1Instrument, Manual, Surgical, General Use 1Speculum, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221524	Sugita AVM Microclip Applier	2022-06-24
US	K211183	Sugita AVM Microclips	2022-03-02
US	K990202	SUGITA TITANIUM ANEURYSM CLIP	1999-06-04
BR	10234379018	LawtonElite Micro tesoura - Mizuho	Class II
BR	10234370055	Pinça Articulada - Mizuho	Class I
BR	10234370054	Tesoura - Mizuho	Class I

MIZUHO AMERICA, 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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