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🏥FDA Devices MCP Server

An MCP server that gives AI assistants structured access to FDA medical device databases — 510(k) clearances, PMA approvals, adverse events, recalls, and device classification. Built with TypeScript, includes synonym expansion and source links.

ProjectHealthcareFeatured
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MCP server giving AI assistants structured access to FDA medical device databases

GitHub: prahlaadr/fda-devices-mcp


Why I Built This

Working in healthcare/regulatory, needed a way to let Claude query FDA device databases naturally — 510(k) clearances, PMA approvals, adverse events, recalls, classification. No existing MCP server covered medical devices.

How It Works

TypeScript MCP server with 5 tools: classify_device, search_510k, search_pma, search_adverse_events, search_recalls. Each tool queries openFDA APIs with intelligent parameter mapping. Includes medical device synonym expansion so "heart valve" finds "cardiac valve" too. Every result includes direct FDA source links.

Notable Technical Details

  • Synonym expansion for medical device terminology
  • 510(k) bridge fallback for finding predicate devices
  • Published on npm as an installable package
  • Direct FDA source links included in every response