FDA MAUDE Intelligence MCP

AI agent MCP server for medtech peer benchmarking. Compare device manufacturers' safety profiles against product-code peers using FDA MAUDE adverse event data, 510(k) clearance records, and FDA enforcement actions.

MCP Endpoint: https://fda-maude-intelligence-mcp.apify.actor/mcp GitHub: red-cars-io/fda-maude-intelligence-mcp No API key required.

1. Quick Start

Add this MCP server to Claude Desktop, Cursor, or Windsurf:

{
  "mcpServers": {
    "fda-maude-intelligence": {
      "command": "npx",
      "args": ["-y", "@apify/fda-maude-intelligence-mcp"]
    }
  }
}

Or connect via remote MCP endpoint:

{
  "mcpServers": {
    "fda-maude-intelligence": {
      "url": "https://fda-maude-intelligence-mcp.apify.actor/mcp"
    }
  }
}

2. What Data Can You Access?

FDA Data Source	Endpoint	Covers
MAUDE (Manufacturer and User Facility Device Experience)	`api.fda.gov/device/event.json`	Adverse event reports, device failures, injuries, deaths
510(k) Premarket Notifications	`api.fda.gov/device/510k.json`	Device clearance history, predicate devices, submission dates
Medical Device Enforcement Reports	`api.fda.gov/device/enforcement.json`	Recalls, corrections, removals

All three APIs are public and require no API key.

3. Why Use FDA MAUDE Intelligence MCP?

Peer benchmarking — compare any two device manufacturers against their product-code cohort using risk-adjusted percentile scoring. No other actor in the Apify store does this.
No API key required — FDA public APIs are open. Zero credentials to manage.
LLM-optimized JSON output — every tool returns structured data designed for AI agent consumption, not raw FDA dumps.
Medtech due diligence — VCs, acquirers, and analysts get safety-profile context in seconds, not hours of manual FDA database navigation.
Combined MAUDE + 510(k) + enforcement — cross-reference adverse events with clearance history and recall records in a single session.
Pay-per-event pricing — $0.05 to $0.15 per tool call. No subscription, no minimum spend.

4. Features

Compare two device manufacturers by product code with risk-adjusted composite scores
Trace how component-level recalls cascade to finished device lines
Score a single manufacturer across compliance, adverse event volume, and recall frequency
Monitor quarterly adverse event trends for a device or product code
Pull full 510(k) clearance chronology for any cleared device
Deep-dive into specific recall records including classification, scope, and firm response
Search MAUDE adverse event reports with product code, date range, and event type filters
LLM agent-ready output format — structured JSON with confidence flags
No authentication — FDA public API calls handled server-side
Standalone MCP server — connects to any MCP-compatible AI agent client
Deployed on Apify with standby mode — responds in milliseconds

5. Use Cases

Medtech VC Due Diligence

Compare two cardiac device manufacturers in a single agent session.

{
  "tool": "compare_device_peers",
  "parameters": {
    "company_a": "Medtronic",
    "company_b": "Abbott",
    "product_code": "MDI",
    "date_range": "2020-01-01 to 2024-12-31"
  }
}

Recall Risk Analysis

Track adverse event trends for a pacemaker product line before an acquisition review.

{
  "tool": "track_adverse_event_trends",
  "parameters": {
    "device_name": "Cardiac Pacemaker",
    "product_code": "LTO",
    "quarters": 8
  }
}

Competitive Intelligence

Benchmark safety profiles across peer companies in the orthopedic implant space.

{
  "tool": "score_manufacturer",
  "parameters": {
    "company_name": "Stryker",
    "product_code": "HSD",
    "date_range": "2022-01-01 to 2024-12-31"
  }
}

Component Recall Tracing

Trace how a supplier recall cascades to OEM finished device lines.

{
  "tool": "analyze_recall_chain",
  "parameters": {
    "component_recall_id": "BK-2020-12345",
    "finish_device_manufacturer": "Boston Scientific"
  }
}

6. How to Connect

Step 1: Add the MCP server configuration to your AI agent client (Claude Desktop, Cursor, or Windsurf).

Step 2: Use the remote endpoint https://fda-maude-intelligence-mcp.apify.actor/mcp for zero-setup connectivity, or install via npx @apify/fda-maude-intelligence-mcp.

Step 3: Verify connectivity by calling search_adverse_events with a test product code.

Step 4: Call any of the 7 tools to pull FDA data. No API key needed.

7. MCP Tools Reference

Tool	Price	Best for
`compare_device_peers`	$0.15	Comparing two companies by product code, risk-adjusted
`analyze_recall_chain`	$0.10	Tracing component recall cascade to finished devices
`score_manufacturer`	$0.08	Single-company compliance score and risk surface
`track_adverse_event_trends`	$0.08	QoQ adverse event trend with deltas
`get_device_clearance_history`	$0.05	510(k) clearance chronology
`get_recall_details`	$0.05	Deep dive on a specific recall
`search_adverse_events`	$0.05	MAUDE event search with filters

8. Tool Parameters

compare_device_peers

Parameter	Type	Required	Description
`company_a`	string	Yes	First company name
`company_b`	string	Yes	Second company name
`product_code`	string	Yes	FDA product code (e.g., `MDI`, `LTO`, `HSD`)
`date_range`	string	No	Date range in `YYYY-MM-DD to YYYY-MM-DD` format

analyze_recall_chain

Parameter	Type	Required	Description
`component_recall_id`	string	Yes	FDA enforcement report ID
`finish_device_manufacturer`	string	No	Filter to a specific OEM manufacturer

score_manufacturer

Parameter	Type	Required	Description
`company_name`	string	Yes	Full legal company name
`product_code`	string	No	Filter to a specific product code
`date_range`	string	No	Date range in `YYYY-MM-DD to YYYY-MM-DD` format

track_adverse_event_trends

Parameter	Type	Required	Description
`device_name`	string	No	Device name or brand name
`product_code`	string	No	FDA product code
`quarters`	integer	Yes	Number of quarters to analyze (max 20)

get_device_clearance_history

Parameter	Type	Required	Description
`device_name`	string	Yes	Device name as it appears in 510(k) database

get_recall_details

Parameter	Type	Required	Description
`recall_id`	string	Yes	FDA recall identifier

search_adverse_events

Parameter	Type	Required	Description
`device_name`	string	No	Device name
`product_code`	string	No	FDA product code
`date_range`	string	No	Date range in `YYYY-MM-DD to YYYY-MM-DD` format
`event_type`	string	No	Filter by event type (e.g., `death`, `injury`, `malfunction`)

9. Connection Examples

Claude Desktop

{
  "mcpServers": {
    "fda-maude-intelligence": {
      "url": "https://fda-maude-intelligence-mcp.apify.actor/mcp"
    }
  }
}

cURL (MCP protocol)

curl -X POST https://fda-maude-intelligence-mcp.apify.actor/mcp \
  -H "Content-Type: application/json" \
  -d '{"jsonrpc":"2.0","method":"tools/call","params":{"name":"search_adverse_events","arguments":{"product_code":"MDI","date_range":"2023-01-01 to 2024-12-31"}},"id":1}'

Cursor

Add to Cursor AI settings under MCP Servers using the remote endpoint URL.

Windsurf

Add to Windsurf MCP settings using the same remote endpoint configuration.

10. Output Example — compare_device_peers

{
  "peer_comparison": {
    "company_a": {
      "name": "Medtronic",
      "product_code": "MDI",
      "adverse_event_count": 1847,
      "recall_count": 3,
      "risk_percentile": 72,
      "compliance_score": 68
    },
    "company_b": {
      "name": "Abbott",
      "product_code": "MDI",
      "adverse_event_count": 1204,
      "recall_count": 1,
      "risk_percentile": 41,
      "compliance_score": 81
    },
    "comparator": {
      "product_code_peers": 23,
      "cohort_avg_adverse_events": 1350,
      "cohort_avg_recall_count": 1.8,
      "winner": "Abbott",
      "delta": {
        "risk_percentile_a_vs_b": 31,
        "compliance_score_delta": 13
      }
    }
  }
}

11. Output Fields Explained

Field	Description
`risk_percentile`	Where this manufacturer falls in its product-code cohort. Higher = worse safety profile.
`compliance_score`	Composite 0-100 score combining event rate, recall frequency, and enforcement history.
`adverse_event_count`	Total MAUDE reports filtered to company + product code + date range.
`recall_count`	Number of distinct FDA enforcement actions in the period.
`cohort_avg_*`	Benchmark values for all companies sharing the same product code.
`delta`	Difference between the two peer companies on risk percentile and compliance score.
`winner`	The better-performing company based on risk-adjusted composite scoring.

12. Pricing

All tools use Apify Pay-Per-Event (PPE) pricing. No monthly fee, no subscription, no minimum spend.

Tool	Price per call
`compare_device_peers`	$0.15
`analyze_recall_chain`	$0.10
`score_manufacturer`	$0.08
`track_adverse_event_trends`	$0.08
`get_device_clearance_history`	$0.05
`get_recall_details`	$0.05
`search_adverse_events`	$0.05

View on Apify Store: FDA MAUDE Intelligence MCP

13. How It Works

The FDA MAUDE Intelligence MCP runs as an Apify Standby Actor with a full MCP protocol interface. When an AI agent calls a tool:

Request received — MCP JSON-RPC call hits the standby endpoint
FDA API query — actor queries the relevant api.fda.gov endpoint (MAUDE, 510(k), or enforcement) with the tool parameters
Risk calculation — adverse event counts are normalized against product-code cohort size and weighted by event severity
Composite scoring — percentile rank and compliance score computed from normalized metrics
JSON response — structured output returned to the AI agent via MCP protocol

Data flows directly from FDA public APIs through the actor to the AI agent. No data is stored. No API key required — the actor handles all FDA API communication server-side.

14. Tips for Best Results

Use product codes — product_code filters are the most precise way to isolate device types. Use FDA product code lookups when possible.
Scope with date ranges — filter to the relevant review period (e.g., last 2-3 years) for fresher adverse event data.
Combine for due diligence — run score_manufacturer first for a single-company summary, then compare_device_peers for a head-to-head.
Check 510(k) history — use get_device_clearance_history when evaluating pre-market status of a target's device portfolio.
Run recall chain early — analyze_recall_chain surfaces supplier-level risk before component issues hit finished device lines.
Use event_type filter — when researching device safety, filter to death or injury events to cut through low-severity noise.

15. Combine with Other Actors

FDA MAUDE Intelligence MCP pairs with related actors for deeper due diligence:

Healthcare Compliance MCP — expands device-level findings into full regulatory compliance audits covering FDA 483 observations, warning letters, and import alerts.

Company Intelligence MCP — cross-references the same company against sanctions lists (OFAC, BIS), debarment records, and adverse media.

Patent Search MCP — looks up 510(k) numbers to find associated patent filings. K-numbers from the clearance history map directly to patent search queries.

Run all three in a single agent session for a complete medtech acquisition target profile.

16. Related Actors

Healthcare Compliance MCP — FDA regulatory compliance for device manufacturers
Company Intelligence MCP — sanctions screening and adverse media for medtech companies
Patent Search MCP — patent lookup by 510(k) K-number

17. Troubleshooting

MCP connection fails Verify the remote endpoint URL is correct: https://fda-maude-intelligence-mcp.apify.actor/mcp. Check that your AI agent client supports remote MCP servers.

No data returned FDA public APIs occasionally return empty result sets for obscure product codes. Try broadening the date range or using a more common device name.

Tool returns unexpected fields The actor normalizes FDA API responses into a consistent schema. Field names may differ from raw FDA API output. See Section 11 for field definitions.

Rate limiting FDA API has internal rate limits. The actor handles retries automatically. If you need higher throughput, consider batching requests.

18. SEO and LLM Optimization

Meta description: AI agent MCP server for medtech peer benchmarking. Compare device manufacturers' safety profiles using FDA MAUDE, 510(k), and enforcement data. No API key required.

Keywords: AI agent, LLM, MCP server, medtech due diligence, FDA MAUDE, medical device benchmarking, adverse event analysis, 510(k) lookup, recall chain analysis, device compliance score, peer comparison, medtech VC tools, no API key needed,医疗器械, 医疗设备合规, FDA认证

JSON-LD Schema:

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  "url": "https://apify.com/store/mcp/fda-maude-intelligence-mcp",
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    "name": "red-cars-io",
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GitHub topics: mcp-server medtech fda maude medical-devices due-diligence ai-agent llm-tools apify healthcare 510k adverse-events

Name		Name	Last commit message	Last commit date
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.actor		.actor
.github/workflows		.github/workflows
src		src
static		static
test		test
.actorignore		.actorignore
.dockerignore		.dockerignore
.editorconfig		.editorconfig
.gitignore		.gitignore
.npmrc		.npmrc
.prettierignore		.prettierignore
.prettierrc		.prettierrc
AGENTS.md		AGENTS.md
CLAUDE.md		CLAUDE.md
Dockerfile		Dockerfile
README.md		README.md
eslint.config.mjs		eslint.config.mjs
input_schema.json		input_schema.json
llms.txt		llms.txt
package-lock.json		package-lock.json
package.json		package.json
tsconfig.json		tsconfig.json

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