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Home›USA›Olympus Shirakawa Co., Ltd.

Olympus Shirakawa Co., Ltd.

USA · Melville
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
42listed device types
Class I 4Class II 37Class III 0unclassified 1
plus 104 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States104 registration records, 1 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: SHIRAKAWA OLYMPUS CO., LTD.
Same-named companies — This database also contains companies with near-identical names: SHIRAKAWA OLYMPUS CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Melville

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12005 · K042274

FDA listed device types

showing 8 of 42
Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Device, Hardcopy, Images, Ophthalmic 1Laparoscope, Gynecologic (And Accessories) 1Endoscopic Leak Tester 1Laparoscope, General & Plastic Surgery 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1

Registration details (sample)

MarketIdentifierNameClass / date
USK042274PSD-60/ENDOPLASMA2005-02-22

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