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Home›USA›OLYMPUS AMERICA INC. (DIAGNOSTIC SYSTEMS GROUP)

OLYMPUS AMERICA INC. (DIAGNOSTIC SYSTEMS GROUP)

USA · Melville
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
151510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 151 510(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
7active device licences
Class II 4Class III 3
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 States0 registration records, 151 510(k), 0 PMA, 34 excluded
Brazil0 confirmed, 8 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada7 confirmed, 3 excluded
Manufacturer names merged into this page: OLYMPUS AMERICA INC. (DIAGNOSTIC SYSTEMS GROUP) · OLYMPUS AMERICA, INC. · OLYMPUS AMERICA, INC. DIAGNOSTIC SYSTEMS GROUP
Same-named companies — This database also contains companies with near-identical names: Olympus Corp of America. 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

61994
401995
371996
161997
61998
71999
62000
42001
42002
52003
62004
32005
32006
32007
32008
12009
12012

Registration details (sample)

MarketIdentifierNameClass / date
USK111788ENDOEYE HD II2012-01-13
USK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN2009-03-18
USK073489OLYMPUS IGA REAGENT2008-02-11
CA2926INSUFFLATORSClass II
CA1618OLYMPUS CLINICAL CHEMISTRY SYSTEMSClass II
CA73840SINGLE USE BIPOLAR HEMOSTASIS PROBE - SOLARPROBEClass II

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