io.github.pipeworx-io/fda-devices

FDA medical-device regulatory intelligence from keyless openFDA datasets.

GitHub

No known CVEs

MIT license

Actively maintained

Last commit 19d ago

Works with most clients

Transport:

0 tools

Grade F

MCPpedia last refreshed this data 10h ago

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io.github.pipeworx-io/fda-devices is an MCP server that FDA medical-device regulatory intelligence from keyless openFDA datasets. Its tool list has not been published yet, requires no API key, and scores 34/100 on MCPpedia's security, maintenance and efficiency rubric.

Health

Step 1

Install in your client

Config is the same across clients — only the file and path differ.

Supported in Claude Desktopstdio · Node 18+

Paste into ~/Library/Application Support/Claude/claude_desktop_config.json

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

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Read me

What io.github.pipeworx-io/fda-devices does

FDA medical-device regulatory intelligence from keyless openFDA datasets.

Test This Server

No automated test available for this server. Check the GitHub README for setup instructions.

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Scored, not listed

Why this score

Five weighted categories — click any category to see the underlying evidence.

Score breakdown

34/100across 5 weighted dimensions

How we score →

0255075100

−66

Security

Maintenance

Efficiency

Documentation

Compatibility

Categoriesclick a row to see evidence

Security

OSV.dev

No known CVEs.

No package registry to scan.

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Frequently Asked Questions

Is io.github.pipeworx-io/fda-devices safe to use?: io.github.pipeworx-io/fda-devices has no known CVEs as of the latest MCPpedia security scan. It does not require authentication, so any local process can connect — keep this in mind in shared environments. Licensed under MIT.
How do I install io.github.pipeworx-io/fda-devices?: io.github.pipeworx-io/fda-devices supports copy-paste install configs on its MCPpedia page for Claude Desktop, Cursor, and Claude Code. Scroll to the Quick Install section and select your client.
What AI clients work with io.github.pipeworx-io/fda-devices?: io.github.pipeworx-io/fda-devices is compatible with claude-desktop, cursor, claude-code. It uses stdio transport.
Is io.github.pipeworx-io/fda-devices actively maintained?: io.github.pipeworx-io/fda-devices is actively maintained — last commit was 19 days ago.

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Community

Discussion

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Ask a question, share a tip, or report an issue.

Has anyone used this with Cursor?How do you handle auth?Any alternatives?

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.
`fda_device_classification`	Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.
`fda_device_udi_search`	Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.
`fda_device_establishment_search`	Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.
`fda_device_product_code_profile`	Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event rates.

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.

fda_device_classification

Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.

fda_device_udi_search

Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.

fda_device_establishment_search

Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.

fda_device_product_code_profile

Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event 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 1394+ data sources:

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

Frequently Asked Questions

Is io.github.pipeworx-io/fda-devices safe to use?

io.github.pipeworx-io/fda-devices has no known CVEs as of the latest MCPpedia security scan. It does not require authentication, so any local process can connect — keep this in mind in shared environments. Licensed under MIT.

How do I install io.github.pipeworx-io/fda-devices?

io.github.pipeworx-io/fda-devices supports copy-paste install configs on its MCPpedia page for Claude Desktop, Cursor, and Claude Code. Scroll to the Quick Install section and select your client.

What AI clients work with io.github.pipeworx-io/fda-devices?

io.github.pipeworx-io/fda-devices is compatible with claude-desktop, cursor, claude-code. It uses stdio transport.

Is io.github.pipeworx-io/fda-devices actively maintained?

io.github.pipeworx-io/fda-devices is actively maintained — last commit was 19 days ago.

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.
`fda_device_classification`	Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.
`fda_device_udi_search`	Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.
`fda_device_establishment_search`	Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.
`fda_device_product_code_profile`	Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event rates.

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

fda_device_recalls

fda_device_adverse_events

fda_device_event_counts

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.

fda_device_classification

fda_device_udi_search

fda_device_establishment_search

Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.

fda_device_product_code_profile

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 1394+ data sources:

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

io.github.pipeworx-io/fda-devices

Install in your client

What io.github.pipeworx-io/fda-devices does

Test This Server

Why this score

34/100across 5 weighted dimensions

Security

Reviews

Frequently Asked Questions

Similar servers

Discussion

io.github.pipeworx-io/fda-devices

Install in your client

What io.github.pipeworx-io/fda-devices does

Test This Server

mcp-fda-devices

Tools

Quick Start

Using with ask_pipeworx

More

License

Why this score

34/100across 5 weighted dimensions

Security

Reviews

Frequently Asked Questions

Similar servers

Discussion

mcp-fda-devices

Tools

Quick Start

Using with ask_pipeworx

More

License