FDAIntelligence
FDA Device Data API
Every FDA device database. One API. Linked by UDI-DI.
FDA Intelligence connects every FDA medical-device database — device registration (GUDID), 510(k)/PMA clearances, MAUDE adverse events, recalls, and manufacturing establishments — into one linked, queryable API. The entire corpus is mirrored locally, so a single call returns a device’s complete regulatory picture.
Every FDA device database exists in isolation, keyed differently, with no shared identifiers. Answering a simple question — “what is this device’s full safety history?” — means manually stitching five sources together. FDA Intelligence does the stitching: it mirrors 115 GB of FDA device data (including all 24.4M MAUDE reports with narratives, refreshed weekly) and links it by UDI-DI and product code. One REST call — or one plain-English question — returns the fully joined record.
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Adverse Event Reports
24.4M
Devices Linked
5.0M
FDA Sources Linked
8
Status
✅ Live
Logic Layer
GUDID Registry
The linking hub — every device keyed by UDI-DI, carrying the product codes and premarket (510(k)/PMA) numbers that unlock every other source.
510(k) / PMA
Clearance and approval history joined by product code and premarket submission number.
MAUDE Adverse Events
24.4M reports + 57.8M narratives, mirrored locally with precomputed rollups for instant aggregation.
Recalls & Enforcement
Recall records linked by product code and manufacturer, with class and status.
Establishments
Manufacturing-site registrations, deduplicated and ranked to the device’s own maker.
API + NL Query
One REST call — or a plain-English question — returns the fully linked record, structured and cited.
Device Startups
Regulatory research without a data team. Pull a device’s complete clearance, recall, and adverse-event history in one call while scoping a market, a predicate, or a competitor.
Hospital Supply Chain
Monitor recalls and safety signals across every device you stock — query by manufacturer, product code, or specific device, and catch Class I recalls the moment they publish.
Health-IT Vendors
Embed live FDA device intelligence in your EHR, procurement, or risk product without building and maintaining six separate ETL pipelines against FDA data.
Litigation & Law Firms
Assemble a device’s full regulatory and adverse-event record as cited, defensible evidence — in seconds, not weeks of manual cross-referencing.
Insurers & Risk Teams
Score device and manufacturer risk from linked recall and adverse-event data, refreshed weekly — inputs no single FDA endpoint can give you.
Researchers
Post-market surveillance at scale: the entire MAUDE corpus with narratives, joined to devices, manufacturers, and product codes.
The linking is the moat
Every FDA device database is siloed. We join them on UDI-DI and product code, so you can ask cross-source questions no single FDA API can answer — “recalls on devices made at a facility in the last 3 years” — in one query.
The full corpus, mirrored
115 GB of FDA device data — including all 24.4M MAUDE reports with narratives — mirrored locally and refreshed weekly. Your queries never depend on FDA uptime.
Ask in plain English
A natural-language mode powered by Claude turns “Medtronic cardiac devices recalled since 2023” into structured, cited results. No query language to learn.
Sub-second linked queries
Precomputed rollups turn a 24-million-row adverse-event aggregation into a primary-key lookup — a full linked device report returns in well under a second.
Self-serve, metered API
Free tier through enterprise, with per-account keys, usage metering, and Stripe billing. Get a key and start in minutes — no sales call.
Discoverable by design
Millions of public, SEO-optimized device, manufacturer, and product-code pages make the data findable on the open web — and funnel straight to the API.
Linked API across GUDID, 510(k)/PMA, MAUDE, and recalls — joined by UDI-DI and product code, with live openFDA query mode.
Complete 115 GB local mirror of all 8 FDA sources with narratives; natural-language search (Claude); precomputed adverse-event rollups; commercial layer — API keys, metering, tiers, Stripe billing, accounts, and email.
Production deployment; programmatic SEO — millions of public device, manufacturer, and product-code pages plus in-depth guides; billing live.
Manufacturer entity normalization, bulk export, webhook alerts on new recalls/events, enterprise SSO, AI narrative summarization across 57.8M MAUDE texts, and device risk-scoring models.
Want to see FDA Intelligence in action? We run guided walkthroughs tailored to your organization — in person or over Zoom. Book a time that works for you.
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