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Canon USA, Inc.

USA · Lake Success
✓ 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
3listed device types
Class I 0Class II 3Class III 0
plus 13 registration records and 49 510(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
11active device licences
Class II 10Class III 1
14 including historic records
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 States13 registration records, 49 510(k), 0 PMA, 16 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada11 confirmed, 6 excluded
Manufacturer names merged into this page: Canon Medical Diagnostics USA, Inc. · CANON MEDICAL SYSTEMS, USA.
Same-named companies — This database also contains companies with near-identical names: Canon Medical Diagnostics USA, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Lake Success

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

41984
61985
51986
41987
31988
31989
11990
11991
61994
31995
11997
21998
11999
12000
32002
32003
12009
12018

FDA listed device types

Ige, Antigen, Antiserum, Control 1System, Test, Radioallergosorbent (Rast) Immunological 1System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens 1

Registration details (sample)

MarketIdentifierNameClass / date
USK182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A2018-09-14
USK090623DIGITAL RADIOGRAPHY CXDI-40G COMPACT2009-03-24
USK033624PACS SOFTWARE SOLUTION 20032003-12-15
CA84712RADPRO MOBILE 3 40KW (DIGITAL MOBILE X-RAY SYSTEM)Class II
CA84713RADPRO URS (UNIVERSAL RADIOGRAPHY SYSTEM)Class II
CA84715RADPRO FM-1 (FLOOR MOUNTED RADIOGRAPHY SYSTEM)Class II

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