FDA Medical Device Compliance Data — MCP Server

Access FDA MAUDE adverse event reports, 510(k) premarket clearances, device recall tracking, and ClinicalTrials.gov trial registry data for medical device compliance research and AI agent regulatory intelligence.

This MCP server connects AI agents directly to the FDA's publicly available medical device databases — no API keys required. Query adverse event reports, verify premarket clearance status, track Class I/II/III device recalls, and screen manufacturers for compliance risk across the full FDA device ecosystem.

Features

• FDA MAUDE Adverse Events — Search millions of medical device adverse event reports submitted by manufacturers since 1991. Filter by device type, manufacturer, date range, and outcomes to identify safety signals and product liability intelligence.
• FDA 510(k) Clearances — Look up FDA premarket clearance records for specific devices. Verify clearance numbers, substantial equivalence determinations, and clearance dates for any 510(k)-cleared medical device on the US market.
• FDA Device Recalls — Track FDA Class I (most serious), Class II, and Class III medical device recalls by manufacturer, product code, or classification date. Monitor ongoing recall status and correction/removal actions.
• ClinicalTrials.gov Registry — Search global clinical device trials by condition, intervention, sponsor, and recruitment status. Access trial details including design, eligibility criteria, enrollment numbers, and primary completion dates.
• Compliance Screening — Composite compliance assessment for any medical device or manufacturer. Aggregate MAUDE event counts, recall history, and 510(k) clearances into a single risk score with HIGH/MEDIUM/LOW risk classification.
• Manufacturer Quality Assessment — Assess FDA-regulated manufacturer quality based on adverse event frequency, recall severity, and clearance history. Compare manufacturers within device categories.
• Compliance Reporting — Generate comprehensive FDA compliance reports for regulatory submissions, due diligence reviews, or investment analysis. Includes MAUDE events, recalls, 510(k) history, and clinical trial data in a single structured output.
• No API Key Required — All FDA and ClinicalTrials.gov data is publicly available. Connect your AI agent in seconds without managing credentials.

Quick Start

Add to your MCP client configuration:

{
  "mcpServers": {
    "healthcare-compliance-mcp": {
      "url": "https://healthcare-compliance-mcp.apify.actor/mcp"
    }
  }
}

No authentication required. The actor runs on Apify's infrastructure and handles all FDA/ClinicalTrials.gov requests.

Data Sources

Source	Coverage	Data Available
FDA MAUDE	United States	Medical device adverse event reports (mandatory manufacturer submissions since 1991)
FDA 510(k)	United States	Premarket notification clearance records, substantial equivalence determinations
FDA Recalls	United States	Class I/II/III medical device recall actions, correction/removal descriptions
ClinicalTrials.gov	Global	Device trials, interventional studies, observational studies by condition

Tools

Tool	Price	Use Case
search_device_events	$0.05	Find adverse event reports for a specific medical device or manufacturer
get_device_510k_clearance	$0.03	Retrieve 510(k) clearance details for a specific device
get_device_recalls	$0.05	List FDA device recalls by manufacturer or product category
search_clinical_trials	$0.05	Discover device-related clinical trials on ClinicalTrials.gov
get_trial_details	$0.03	Get detailed information for a specific clinical trial
screen_device_compliance	$0.10	Composite compliance screen with risk score for a device or manufacturer
assess_manufacturer_quality	$0.08	Quality assessment based on FDA compliance history
generate_compliance_report	$0.15	Full compliance report for regulatory or investment due diligence

search_device_events

When to use: AI agent investigating medical device safety signals, adverse event patterns, or product liability cases.

Example: "Search FDA MAUDE for adverse event reports involving insulin pumps in the last 3 years — show devices with the most serious outcomes."

search_device_events(device_name="insulin pump", max_results=10)

get_device_510k_clearance

When to use: AI agent verifying FDA clearance status for a medical device before procurement, clinical use, or regulatory submission.

Example: "Did Medtronic receive 510(k) clearance for their pacemaker lead model? What's the clearance number and date?"

get_device_510k_clearance(device_name="pacemaker lead")

get_device_recalls

When to use: AI agent tracking device recall status for clinical risk management, procurement decisions, or post-market surveillance.

Example: "Show me all Class I and Class II recalls for devices made by Johnson & Johnson's DePuy subsidiary in the last 5 years."

get_device_recalls(manufacturer="DePuy", recall_class=["I", "II"])

screen_device_compliance

When to use: AI agent performing pre-purchase due diligence on a medical device vendor or comparing compliance profiles across manufacturers.

Example: "Screen Boston Scientific's compliance profile — check their MAUDE events, recalls, and 510(k) history."

screen_device_compliance(device_name="coronary stent", manufacturer="Boston Scientific")

generate_compliance_report

When to use: AI agent producing a comprehensive medical device compliance assessment for regulatory submissions, investment analysis, or acquisition due diligence.

Example: "Generate a full FDA compliance report for Philips' respiratory device division covering 2019-2024."

generate_compliance_report(manufacturer="Philips", product_category="respiratory", year_start=2019, year_end=2024)

Input Parameters

Parameter	Type	Required	Description
device_name	string	Yes (most tools)	Name of the medical device to search
manufacturer	string	No	Manufacturer name to filter results
max_results	integer	No	Maximum number of results (default: 10)
date_range	object	No	{start: "YYYY-MM-DD", end: "YYYY-MM-DD"}
recall_class	array	No	Filter by recall class: ["I", "II", "III"]

Output Format

All tools return structured JSON with consistent fields:

{
  "status": "success",
  "data": {
    "device_name": "Insulin Infusion Pump",
    "manufacturer": "Medtronic",
    "total_results": 847,
    "events": [
      {
        "event_id": "20234567890",
        "device_name": "Insulin Infusion Pump",
        "manufacturer": "Medtronic",
        "adverse_event_description": "Battery depletion leading to interrupted therapy",
        "date_of_event": "2023-08-15",
        "source": "FDA MAUDE"
      }
    ],
    "compliance_score": 82,
    "risk_level": "LOW"
  }
}

Pricing

Pay-per-use via Apify PPE. No subscription, no monthly minimum.

Tool	Per Call
search_device_events	$0.05
get_device_510k_clearance	$0.03
get_device_recalls	$0.05
search_clinical_trials	$0.05
get_trial_details	$0.03
screen_device_compliance	$0.10
assess_manufacturer_quality	$0.08
generate_compliance_report	$0.15

Estimate total cost based on your expected query volume. Most compliance screens use 3-5 tool calls per device.

Troubleshooting

Tool returns no results: Verify the device name spelling — FDA databases use specific nomenclature. Try broader terms (e.g., "heart valve" instead of specific model numbers).

Compliance score missing: The actor aggregates data from multiple FDA sources. If a device has no MAUDE events, recalls, or 510(k) records, the score may be unavailable and null will be returned.

Rate limiting: Apify implements internal rate limiting. For high-volume compliance screening, add delay between requests or contact Apify for dedicated capacity.

Clinical trial data outdated: ClinicalTrials.gov updates registration data continuously. Trial status (recruiting, completed, terminated) reflects the most recent sponsor submission.

Use Cases

• Medical Device Due Diligence — Verify FDA clearance status and adverse event history before acquiring or licensing device technology.
• Product Liability Research — Identify adverse event patterns and recall history for litigation support.
• Regulatory Compliance Monitoring — Track manufacturer compliance status for quality management systems and post-market surveillance.
• Clinical Trial Intelligence — Find active device trials for competitive analysis or patient referral coordination.
• Investment Due Diligence — Screen medical device manufacturers for FDA compliance risk as part of investment evaluation.

Connect to AI Agents

Claude Desktop

Add to your Claude Desktop MCP settings:

{
  "mcpServers": {
    "healthcare-compliance-mcp": {
      "url": "https://healthcare-compliance-mcp.apify.actor/mcp"
    }
  }
}

Cursor / Windsurf / Other MCP Clients

Any MCP-compatible client can connect using the same URL. No API key configuration needed.

Related Resources

• COMPARISON.md
• FDA MAUDE Database
• FDA 510(k) Database
• FDA Device Recalls Database
• ClinicalTrials.gov

Keywords

FDA MAUDE API, medical device adverse events, 510(k) clearance lookup, FDA device recalls, ClinicalTrials.gov API, medical device compliance, AI agent FDA research, medical device due diligence, FDA regulatory intelligence, clinical trial search API, medtech compliance, device safety signals, AI agent healthcare, medical device recall tracking, FDA premarket notification