FDA
FDA Enforcement Reports →Drug and device recall enforcement reports — recalling firm, classification, reason, and status from the openFDA enforcement feeds.
FDA Device Establishment Registration
FDA device establishment registration and listing — registration number, firm name, establishment type, and location. Source:
FHIR Organization · Sample record
What a record looks like in the API response.
{
"resourceType": "Organization",
"id": "fda-est-example",
"_source": "fda-establishment-registrations",
"_methodology": "fda-establishment/v1",
"name": "Example Device Firm",
"extension": [{ "url": "establishmentType", "valueString": "Manufacturer" }]
}Every record carries _source, _methodology, a snapshot date, and a confidence tier. All fourteen provenance fields survive export and API delivery.
curl -H "Authorization: Bearer $FONTEUM_KEY" \ "https://api.fonteum.com/fhir/r4/Organization?_source=fda-establishment" \ | jq '._source, ._methodology, .meta.tag'
Dataset facts
| Field | Value |
|---|---|
| Agency | |
| Category | Drug and device safety |
| Records | |
| Temporal coverage | 2007–2026 |
| Refresh cadence | Weekly |
| Freshness SLA | Within 7 days of openFDA refresh |
| Last synced | 2026-06-14Updated 2026-06-14 |
| FHIR resource | Organization |
| Methodology | fda-establishment/v1 |
| Measured | Registration number, FEI number, firm name, establishment type, and location per establishment |
| Upstream source | api.fda.gov → |
Get access
How to reach this dataset.
API access is operator-approved during the pilot. Reviewed within one business day. No charge during the pilot period.