Pipeworx Fda Devices MCP MCP server

An MCP server providing regulatory intelligence for FDA medical devices by querying openFDA datasets. It offers tools to search 510(k) notifications, Premarket Approvals, recalls, adverse events, and device classifications, enabling agents to build company profiles and product code snapshots for compliance and research.

Endpoint and access

No sign-in: your client connects and lists tools immediately, with no account or key.

No sign-inEndpoint checked 2026-10-05Operated by Pipeworx

MCP endpoint (Streamable HTTP)

https://gateway.pipeworx.io/fda-devices/mcp

Vendor documentation

What you can do with it

Search FDA 510(k) premarket notifications by device or applicant
Retrieve FDA Premarket Approval (PMA) decisions and supplements
Search medical-device recall records and adverse event reports
Build regulatory snapshots for specific device companies or product codes

Tools advertised by the last live check:

ask_pipeworx
ask_pipeworx_beta
ask_pipeworx_grounded
search_within
deep_research
discover_tools
resolve_entity
compare_entities
subscribe
unsubscribe
list_subscriptions
recent_alerts
entity_profile
recent_changes
validate_claim
company_facts
scan_dependency
bet_research
polymarket_arbitrage
polymarket_edges
polymarket_kalshi_spread
polymarket_fill_risk
polymarket_edge_tracker
kalshi_weather_edge
resolution_audit
resolution_diff
release_calendar_markets
pipeworx_trending
suggest_questions
generate_llms_txt
ai_visibility_check
scan_competitor_ai_presence
pipeworx_feedback
remember
recall
forget
fda_device_510k_search
fda_device_510k_summary
fda_device_pma_search
fda_device_recalls
fda_device_adverse_events
fda_device_event_counts
fda_device_company_profile
fda_device_classification
fda_device_udi_search
fda_device_establishment_search
fda_device_product_code_profile

Connect from your client

Each snippet registers the same endpoint; pick the client you use.

This server is operated by the named third party. Listing and endpoint checks are not an endorsement or a security audit. Review the operator's permissions, terms, and data handling before connecting. How listings are checked and corrected.

Claude Code

Run this once in a terminal. It registers a Streamable HTTP server. Use --scope project to write .mcp.json for the repo.

Claude Code configuration

claude mcp add --transport http pipeworx-fda-devices-mcp https://gateway.pipeworx.io/fda-devices/mcp

Codex

Run this once. Codex stores MCP servers in ~/.codex/config.toml (or .codex/config.toml in a trusted project).

Codex configuration

codex mcp add pipeworx-fda-devices-mcp --url https://gateway.pipeworx.io/fda-devices/mcp

Cursor

Merge this server into .cursor/mcp.json in your project, then enable pipeworx-fda-devices-mcp in your MCP settings.

Cursor configuration

{
  "mcpServers": {
    "pipeworx-fda-devices-mcp": {
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

Cline

Merge this into cline_mcp_settings.json (Cline → MCP Servers → Configure). The type must be streamableHttp for a remote HTTP server.

Cline configuration

{
  "mcpServers": {
    "pipeworx-fda-devices-mcp": {
      "type": "streamableHttp",
      "url": "https://gateway.pipeworx.io/fda-devices/mcp",
      "disabled": false
    }
  }
}

VS Code

Merge this server into .vscode/mcp.json. Use MCP: List Servers to start pipeworx-fda-devices-mcp and inspect its tools.

VS Code configuration

{
  "servers": {
    "pipeworx-fda-devices-mcp": {
      "type": "http",
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

Gemini CLI

Run this once. It writes .gemini/settings.json in the current project; pass --scope user for ~/.gemini/settings.json.

Gemini CLI configuration

gemini mcp add --transport http pipeworx-fda-devices-mcp https://gateway.pipeworx.io/fda-devices/mcp

Claude Desktop

Merge this into claude_desktop_config.json (macOS: ~/Library/Application Support/Claude/, Windows: %APPDATA%\Claude\), then restart Claude Desktop.

Claude Desktop configuration

{
  "mcpServers": {
    "pipeworx-fda-devices-mcp": {
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

Windsurf

Merge this into ~/.codeium/windsurf/mcp_config.json, then refresh MCP in Cascade. Windsurf remote servers use serverUrl, not url.

Windsurf configuration

{
  "mcpServers": {
    "pipeworx-fda-devices-mcp": {
      "serverUrl": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

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