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FDA medical-device regulatory intelligence from keyless openFDA datasets.
About
FDA medical-device regulatory intelligence from keyless openFDA datasets.
Remote endpoints: streamable-http: https://gateway.pipeworx.io/fda-devices/mcp
Security Report
10.0
Low Risk10.0Low RiskValid MCP server (1 strong, 0 medium validity signals). No known CVEs in dependencies. Imported from the Official MCP Registry. Trust signals: trusted author (1262/1275 approved). 1 finding(s) downgraded by scanner intelligence.
37 tools verified · Open access · 1 issue found
Security scores are indicators to help you make informed decisions, not guarantees. Always review permissions before connecting any MCP server.
Permissions Required
This plugin requests these system permissions. Most are normal for its category.
How to Connect
Remote Plugin
No local installation needed. Your AI client connects to the remote endpoint directly.
Add this to your MCP configuration to connect:
{
"mcpServers": {
"io-github-pipeworx-io-fda-devices": {
"url": "https://gateway.pipeworx.io/fda-devices/mcp"
}
}
}Documentation
View on GitHubFrom the project's GitHub README.
mcp-fda-devices
FDA medical-device regulatory intelligence from keyless openFDA datasets.
Part of Pipeworx — an MCP gateway connecting AI agents to 1361+ live data sources.
Tools
| Tool | Description |
|---|---|
fda_device_510k_search | Search FDA 510(k) premarket notifications by device, applicant, product code, or K number. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement. |
fda_device_pma_search | Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, or PMA number. Supplements may represent manufacturing or labeling changes rather than new devices. |
fda_device_recalls | Search FDA medical-device recall records by firm, product, product code, K number, status, or date. A recall record describes a correction/removal action and does not by itself establish patient harm. |
fda_device_adverse_events | Search FDA MAUDE medical-device reports by manufacturer, brand/device, product code, event type, or PMA/510(k) number. MAUDE reports are unverified signals: they cannot establish causation, incidence, prevalence, or comparative safety. |
fda_device_event_counts | Aggregate MAUDE reports for a device query by event type, manufacturer, product code, or receive date. Counts reflect reporting and database artifacts—not event rates or causal risk—and must not be compared without exposure denominators. |
fda_device_company_profile | Build a bounded FDA regulatory snapshot for one device company across 510(k), PMA, recalls, and MAUDE. Dataset name matching is imperfect and MAUDE counts are signals, not safety rates. |
Quick Start
Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):
{
"mcpServers": {
"fda-devices": {
"url": "https://gateway.pipeworx.io/fda-devices/mcp"
}
}
}
Or connect to the full Pipeworx gateway for access to all 1361+ data sources:
{
"mcpServers": {
"pipeworx": {
"url": "https://gateway.pipeworx.io/mcp"
}
}
}
Using with ask_pipeworx
Instead of calling tools directly, you can ask questions in plain English:
ask_pipeworx({ question: "your question about Fda Devices data" })
The gateway picks the right tool and fills the arguments automatically.
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License
MIT
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