FDA
FDA Device Establishment Registration →FDA device establishment registration and listing — registration number, firm name, establishment type, and location.
FDA Enforcement Reports
Drug and device recall enforcement reports — recalling firm, classification, reason, and status from the openFDA enforcement feeds. Source:
FHIR Organization · Sample record
What a record looks like in the API response.
{
"resourceType": "Organization",
"id": "fda-firm-example",
"_source": "fda-enforcement-reports",
"_methodology": "fda-enforcement/v1",
"name": "Example Manufacturer Inc.",
"extension": [{ "url": "recallClassification", "valueString": "Class II" }]
}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-enforcement" \ | jq '._source, ._methodology, .meta.tag'
Dataset facts
| Field | Value |
|---|---|
| Agency | |
| Category | Drug and device safety |
| Records | |
| Temporal coverage | 2004–2026 |
| Refresh cadence | Weekly |
| Freshness SLA | Within 7 days of openFDA refresh |
| Last synced | 2026-06-14Updated 2026-06-14 |
| FHIR resource | Organization |
| Methodology | fda-enforcement/v1 |
| Measured | Recall number, classification, recalling firm, reason for recall, and status per enforcement report |
| 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.