United States device registration in numbers: 26,108 companies, 282,111 listed device types

This note covers a single market — United States. The official source is FDA openFDA. How many companies and records the database holds here, how classes break down, what share is Chinese, and how to read the figures. Data as of 2026-09-07.

What the database holds here

In United States, 26,108 companies have records, 282,111 listed device types in total, averaging 10.8 each. By company location: USA 10,516, China 4,985, Germany 1,074, Korea, Republic 825, Canada 713, United Kingdom of Great Britain and Northern Ireland 618.

5,817 of those companies are from mainland China, Hong Kong, Taiwan or Macau (22%). 3,531 of the companies here also hold records in five or more markets, which is the multi-market group.

Class distribution

I 159,301, II 112,161, III 5,441, U 5,208.

Class fields are defined differently in each jurisdiction and do not map across markets: EU Class IIa/IIb is not the same thing as China Class II, and the evidence route for US Class II differs from EU Class IIa. Which column each class figure is taken from is listed at the methodology page.

Companies with the most records

Company	Country	listed device types	Markets
Sterigenics U.S., LLC	USA	1,387	1
Isomedix Operations, Inc.	USA	1,235	1
Sterigenics UK Limited	United Kingdom of Great Britain and Northern Ireland	1,060	1
Medline Industries, Inc.	USA	753	9
Aspen Surgical Corp.	USA	655	11
MEDLINE INDUSTRIES, LP - Northfield	USA	622	1
Teleflex Medical de Mexico, S. de R.L. de C.V.	Mexico	556	5
TELEFLEX MEDICAL BRASIL LTDA	—	549	11
TELEFLEX MEDICAL EUROPE LIMITED	Ireland	549	6
Cardinal Health, Inc.	USA	523	6
Cardinal Health K.K.	Japan	523	7
Falcon Surgical Co. (Pvt.) Ltd.	Pakistan	523	3

How much was excluded during verification

In this market the database excluded 515,930 records that matched by name but belong to different companies. The exclusion volume is itself a data-quality signal: the more that is excluded, the looser the registry search interface, and the larger the error from using raw hit counts.

How to verify this yourself

Every market figure on this site is the result of **re-checking each manufacturer name record by record**, not a raw hit count from a registry search interface. Name search in these registries is generally a substring match: searching EUDAMED for "Edan" returns 1,933 records, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the United States — taking the raw count would overstate by more than 60 percent. We therefore require the distinctive token to appear as a whole word and demand a genuinely distinguishing shared token; generic words such as "medical" or "systems" never qualify on their own, and the similar names that were excluded are listed on each company page. Each market counts a different unit (the EU counts UDI-DI device records, the US counts listed device types, Canada and Brazil count valid registrations, Korea counts quality-system certifications), so figures cannot be summed or compared across markets. The full basis, official portals and query paths are at the methodology page.

This database; source data from FDA openFDA