FDA Medical Device Database — 510(k), PMA, Recalls & MAUDE

Unified access to all FDA medical device endpoints via the free openFDA API. Search 175K+ 510(k) premarket notifications, 55K+ PMA approvals, 58K+ device recalls, 24M+ MAUDE adverse events, and full device classification — all from one actor. No API key required.

Why this actor? Most FDA actors focus on a single endpoint (recalls only, or events only). This one covers the entire device lifecycle — premarket clearance, approval, post-market surveillance, and recalls — with cleaned manufacturer names, normalized device names, and specialty mapping.

Features

• 🔬 5 endpoints in 1: 510(k), PMA, Recalls, MAUDE adverse events, Classification
• 🧹 Smart normalization: Manufacturer name deduplication (200+ known brands), legal suffix stripping, device name cleaning
• 📊 Human-readable output: Formatted summary tables with key fields
• 🏷️ Medical specialty tagging: Auto-detects specialty from product codes (Cardiovascular, Orthopedic, Neurology, etc.)
• 🔍 Flexible filtering: Search by device name, manufacturer, product code, date range
• 💰 Pay-per-result: Only charged for records you actually retrieve

Input Parameters

Parameter	Type	Required	Description
endpoint	select	✅	FDA endpoint: 510(k), PMA, Recall, MAUDE, or Classification
searchQuery	string	❌	Search for device name, manufacturer, or product code
manufacturer	string	❌	Filter by manufacturer/applicant name (e.g. "Medtronic")
productCode	string	❌	FDA 3-letter product code (e.g. "DQY" for pacemakers)
dateFrom	string	❌	Start date in YYYYMMDD format (e.g. 20230101)
dateTo	string	❌	End date in YYYYMMDD format (e.g. 20231231)
maxResults	integer	❌	Maximum results (1–1000). Default: 50

Example Input

{
  "endpoint": "510k",
  "searchQuery": "pacemaker",
  "maxResults": 10
}

{
  "endpoint": "recall",
  "manufacturer": "Medtronic",
  "dateFrom": "20240101",
  "maxResults": 25
}

{
  "endpoint": "maude",
  "productCode": "DQY",
  "dateFrom": "20230101",
  "dateTo": "20231231",
  "maxResults": 50
}

Example Output

==========================================================================================
  FDA MEDICAL DEVICE DATABASE — 510(k) Premarket Notifications
==========================================================================================
  Endpoint:     510k
  Retrieved:    10 records

  #  K Number      Device Name                           Applicant                  Decision
───  ────────────  ───────────────────────────────────  ────────────────────────  ───────────────
  1  K230001       Pacemaker Lead                        Medtronic                 Substantially Equivalent (SE)
  2  K230045       Implantable Pacemaker                 Boston Scientific        Substantially Equivalent (SE)
  3  K230078       External Pacemaker Analyzer           Abbott                    Substantially Equivalent (SE)
  ...
==========================================================================================

Use Cases

• Medtech competitive intelligence — Track competitor device approvals and recalls
• Regulatory affairs — Research predicate devices for 510(k) submissions
• Hospital procurement — Monitor device safety recalls and adverse events
• Medical device investing — Due diligence on device manufacturers and product pipelines
• Legal/litigation support — Gather adverse event evidence for plaintiff/defense
• AI/ML pipelines — Feed normalized device data into RAG systems and analytics

Data Source

All data comes from the official openFDA Device API — a free, public U.S. government API with no key or registration required. Data is refreshed regularly by the FDA.

Endpoints used:

• api.fda.gov/device/510k.json — Premarket notifications
• api.fda.gov/device/pma.json — Premarket approvals
• api.fda.gov/device/recall.json — Device recalls/enforcement
• api.fda.gov/device/event.json — MAUDE adverse events
• api.fda.gov/device/classification.json — Device classification

Pricing

$2.00 per 1,000 results (pay-per-event). You only pay for records actually delivered. No charge for empty or failed runs.

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Built by Chris Wakefield — see more FDA & healthcare data actors on the Apify Store.