The dataset
Produced on 2026-08-20. 4 871 European manufacturers with at least 5 devices declared, compared against 24 135 establishments captured from the U.S. FDA register.
Three states, and why
| Matched | 1 193 | the normalised company name exists on both sides |
|---|---|---|
| Not found | 3 448 | no similar name found — this is the product |
| Similar, unverified | 212 | neither matched nor absent; a human must decide |
⚠️ What we do not claim. The two registers share no
identifier. A company absent here may still sell in the United States through a
distributor registered under its own name. We publish the comparison, not a
conclusion about market presence.
⚠️ Substance threshold. Manufacturers with fewer
than 5 declared devices have no page: 27 060 were set aside. Of the
31 931 manufacturers in the European register, only 17 248 have declared a single
device — 14 683 registered without publishing anything.
Access
Every page here is free. The full comparison as a file — with the three states, the matched FDA numbers, device counts and countries — is available on request.
Sources and licences
EUDAMED — European Commission, CC BY 4.0 (Decision 2011/833/EU). openFDA device establishment registrations — U.S. FDA, public domain (CC0 1.0).