Pro access
Are you a regulatory affairs consultancy, a distributor looking for products to represent, a contract manufacturer, or a trade body? This comparison is built on two complete public registers and joined by hand - because they share no key.
What it contains
| Manufacturers compared | 31 931 |
|---|---|
| Matched in the FDA register | 1 193 |
| Not found | 3 448 |
| Similar name, unverified | 212 |
| FDA establishments captured | 24 135 |
Prices
| The full comparison - every European manufacturer, its three-state FDA status, the matched FDA number where there is one, device counts, risk classes and country | CHF 1 800 |
| The absent list only - 3 448 manufacturers not found in the U.S. register, with country, city and device count | CHF 1 200 |
| One country | CHF 300 |
| Quarterly refresh - who has since appeared in the FDA register, and who has left | CHF 600 / quarter |
Delivered as CSV (UTF-8, semicolon) with its field dictionary and its source clause, within two working days.
⚠ What we will not sell you. The quarterly
refresh needs two comparisons to say anything. The first was made on 2026-08-20; the
first real delta will exist a quarter later. Until then it is not for
sale - you would be paying for an empty file.
⚠ And what the file does not settle. A
manufacturer listed as not found may still sell in the United States through a
distributor, or be registered under a name our matching could not reach. On a sample
of ten checked one by one, nine were genuinely absent and one was written
differently. We ship the three states so you can tell them apart - not a verdict.
Ask for it
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). Both are free at source; what is invoiced is the reconciliation, the dating and the delivery.