FDA Regulatory Intelligence: Recalls, Warning Letters, MAUDE Device Events & Company Risk

What you get

• 25,368,161 MAUDE device adverse-event records (row level) + 107,531 product-year aggregates
• 328,054 recall timeline events and 429,354 device recall records
• 175,607 510(k) clearances, 56,798 PMAs, 487 De Novo decisions, 136,520 NDC products
• 92,022 company profiles with heuristic risk scores + 3,236-company clinical-trials crosswalk
• MANIFEST with per-file rows, bytes and sha256 (63 files, 2.4GB archive)

Full package inventory

Every package registered in the delivery catalog for this dataset — 1 packages, 2.4 GB total. Sizes, row counts and SHA-256 checksums come straight from the packaging pipeline.

How to get this data

# Machine-readable package index (size / sha256 / rows / channels)
curl -s https://data.zalize.com/datasets/fda-regulatory-intelligence-dataset/packages.json | jq '.packages[0]'

# Request a free sample (signed link sent to your email)
curl -X POST https://dl.zalize.com/api/sample \
  -H 'Content-Type: application/json' \
  -d '{"dataset":"fda-regulatory-intelligence-dataset","email":"you@company.com"}'

Pricing

Packages for this dataset are being prepared. Grab the free sample below and contact us for current pricing and delivery.

Full-text edition available to qualified buyers on request — contact us.

AI-training use requires the AI-Training tier (1.5× base); redistribution licensing is quoted individually. Annual subscriptions get 2 months free. License details →

Update frequency & delivery

• Sources: openFDA official bulk downloads, fda.gov warning-letter index, accessdata De Novo database.
• Every input source is completeness-gated against openFDA official totals (±0.5%).
• risk_score is a heuristic indicator, not an FDA determination. Delivered as a verified archive after approval — request access.

Compliance & provenance

Collected only from publicly accessible pages and endpoints — no login-required data, no CAPTCHA solving, no forged authentication. Collection is rate-limited with an identified User-Agent, and collection logs are retained. PII is removed or pseudonymized. Every record carries its source URL and collection timestamp. Sold under a tiered commercial license.

FAQ