U.S. Food & Drug Administration (FDA)
FDA Drug Approvals, Device Clearances & Recalls
Drugs@FDA approvals, 510(k)/PMA device decisions, warning-adjacent recalls — as FDA publishes them.
FDA regulatory activity in three streams: drug approvals (Drugs@FDA, NDA/ANDA/BLA), medical-device decisions (510(k) clearances and PMA approvals), and enforcement recalls with classification and reason. Normalized to a sponsor/applicant entity. Records show what FDA published, with the decision or initiation date.
- Records
- 29,227 drug approvals · 232,324 device decisions · 57,353 recalls
- Coverage
- 1939-08-30 → 2026-07-22
- Refresh
- Weekly (approvals/clearances) · weekly (recalls)
- Source
- U.S. Food & Drug Administration (FDA)
What's in it
Tables in this dataset
| Table | Rows | What it holds |
|---|---|---|
| fda_drug_approvals | 29,227 | Drugs@FDA applications: sponsor, ingredient, form, approval dates |
| fda_device_clearances | 232,324 | 510(k) & PMA decisions: applicant, product code, pathway |
| fda_recalls | 57,353 | Enforcement recalls: class, reason, product, firm |
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A few hundred real rows each, released under CC BY 4.0 (the underlying records are U.S. federal works in the public domain). Inspect the schema, then build a Parse for the live feed.
Schema
Key public fields
| Field | Description |
|---|---|
sponsor_name / applicant | Drug sponsor or device applicant |
brand_names / device_name | Product identity |
application_type / pathway | NDA/ANDA/BLA or 510(k)/PMA |
active_ingredients / product_code | Active ingredient or device product code |
classification | Recall class (I/II/III) where applicable |
decision_date / approval_date | FDA decision or approval date |
Provenance
Where every row comes from
Observational data
Every field is a record that exists in a named federal source, with its date — never a score, prediction, or characterization of any company. Public-source records are matched to employers by normalized name and address; match tier and confidence are disclosed on every response. FirmStanding is not a consumer reporting agency and this is not a consumer report — not for use in determining eligibility for employment, credit, insurance, tenancy, or any other purpose regulated by the Fair Credit Reporting Act (FCRA).
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