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Home›USA›Gold Standard Orthopedics, LLC

Gold Standard Orthopedics, LLC

USA · Louisville
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
28listed device types
Class I 12Class II 16Class III 0
plus 62 registration records and 21 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class II 13
19 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
26 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 States62 registration records, 21 510(k), 0 PMA, 23 excluded
Brazil13 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada1 confirmed, 4 excluded
Manufacturer names merged into this page: GOLD STANDARD DIAGNOSTICS, LLC · Gold Standard Diagnostics Frankfurt GmbH · GOLD STANDARD DIAGNOSTICS KASSEL GMBH · GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH · GOLD STANDARD DIAGNOSTICS, LLC. · GOLD STANDARD DIAGNOSTICS
Same-named companies — This database also contains companies with near-identical names: Gold Standard Orthopaedics, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Louisville

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

32007
12009
12011
42012
12013
22014
12015
12018
22020
42021
12025

FDA listed device types

showing 8 of 28
Epstein-Barr Virus, Other 1Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Antiserum, Cf, Epstein-Barr Virus 1Reagents, Cysticercosis 1Reagents, Specific, Analyte 1Elisa, Trichinella Spiralis 1Enzyme Linked Immunoabsorbent Assay, Mumps Virus 1General Purpose Reagent 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System2025-10-10
USK203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit2021-03-22
USK203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit2021-03-22
BR80464810914IgG Screen Nutritional 88 ELISAClass II
BR80464810915IgG4 Screen Nutritional 88 ELISAClass II
BR80464810832Helicobacter pylori IgM ELISAClass II
CA91888THUNDERBOLTClass II

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