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FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.

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Status
Unhealthy
Uptime
73.4% over 43 days
Last Tested
Transport
Streamable HTTP
URL

TDQS

A3.8/5.0

Scored across 7 tools

Disambiguation4/5

Each tool has a clear primary purpose: AI list, predicate research, change feed, clearance detail, stats, recalls, and full-text search. The main overlap is search_records vs search_recalls and product_code_stats vs find_predicates, but their descriptions differentiate scope well enough.

Naming Consistency4/5

Five of seven tools follow a clean verb_noun pattern (find_predicates, get_changes, get_clearance, search_recalls, search_records). ai_devices and product_code_stats break the pattern but are still readable and not confusing.

Tool Count5/5

Seven tools is a well-scoped size for an FDA device data server. Each tool covers a distinct workflow without bloat, and the set is focused enough for agents to navigate.

Completeness4/5

The toolkit covers the main FDA device data workflows: clearance lookup, predicate research, recalls, review-time stats, AI device lists, and change monitoring. Missing dedicated trial or classification endpoints are minor gaps since search_records provides broad fallback coverage.

Tool Schema Changelog

Recent tool additions, removals, and schema changes observed during successful MCP inspections.

  1. 1 tool update
    • Changedsearch_records1 field changed
      • changedInput schema / properties / kind / enum
        Previous value: -[
        -  "clearance",
        -  "recall",
        -  "trial"
        -]New value: +[
        +  "clearance",
        +  "recall",
        +  "trial",
        +  "warning-letter",
        +  "denovo"
        +]
  2. 2 tool updates
    • Addedai_devices
    • Addedsearch_recalls
  3. 5 tool updates
    • First observedfind_predicates
    • First observedget_changes
    • First observedget_clearance
    • First observedproduct_code_stats
    • First observedsearch_records

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