Koskamo

Fda Devices MCP

The Fda Devices MCP server provides 11 tools for querying FDA medical-device regulatory data, including 510(k) notifications, Premarket Approvals, recalls, MAUDE adverse events, UDI records, and establishment registrations. It enables agents to search, aggregate, and profile device safety and compliance information from openFDA datasets.

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Package and access

Local package with source-attributed installation metadata. Koskamo does not execute packages during review.

Fda Devices MCP logo, by PipeworxCommunity listingLocal stdioSource reviewed; not executedPublished by Pipeworx
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 FDA medical-device recall records by firm or product
  • Build a regulatory snapshot for a device company across multiple datasets

Source and maintenance

Community listingRegistry 0.2.1
mcp-registry: io.github.pipeworx-io/fda-devices@0.2.1Source repositoryProject website
Maintenance checked

Packages and installation

Source-provided package data. Koskamo has not executed or live-probed this package.

@pipeworx/mcp-fda-devices 0.2.1

npm
@pipeworx/mcp-fda-devices package definition
{
  "version": "0.2.1",
  "transport": "stdio",
  "identifier": "@pipeworx/mcp-fda-devices",
  "registryType": "npm",
  "environmentVariables": [
    {
      "name": "PIPEWORX_API_KEY",
      "description": "Optional Pipeworx API key. Without it calls are anonymous and capped daily; a free key raises the cap."
    }
  ]
}

Tools

Reported by the attributed source; not independently observed by Koskamo.

No tool definitions available.

Connect from your client

Each snippet configures the same source-provided package; replace placeholders before 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.

Cursor

Merge this local stdio configuration, replace every placeholder environment value, and restart Cursor. Koskamo has not executed this package.
Cursor configuration
{
  "mcpServers": {
    "fda-devices-mcp": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices@0.2.1"
      ],
      "env": {
        "PIPEWORX_API_KEY": "<YOUR_PIPEWORX_API_KEY>"
      }
    }
  }
}

Cline

Merge this local stdio configuration, replace every placeholder environment value, and restart Cline. Koskamo has not executed this package.
Cline configuration
{
  "mcpServers": {
    "fda-devices-mcp": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices@0.2.1"
      ],
      "env": {
        "PIPEWORX_API_KEY": "<YOUR_PIPEWORX_API_KEY>"
      }
    }
  }
}

VS Code

Merge this local stdio configuration, replace every placeholder environment value, and restart VS Code. Koskamo has not executed this package.
VS Code configuration
{
  "servers": {
    "fda-devices-mcp": {
      "type": "stdio",
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices@0.2.1"
      ],
      "env": {
        "PIPEWORX_API_KEY": "<YOUR_PIPEWORX_API_KEY>"
      }
    }
  }
}

Claude Desktop

Merge this local stdio configuration, replace every placeholder environment value, and restart Claude Desktop. Koskamo has not executed this package.
Claude Desktop configuration
{
  "mcpServers": {
    "fda-devices-mcp": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices@0.2.1"
      ],
      "env": {
        "PIPEWORX_API_KEY": "<YOUR_PIPEWORX_API_KEY>"
      }
    }
  }
}

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