{
  "name": "device-safety-mcp",
  "title": "HealthMesh · FDA Device Safety MCP (openFDA + GUDID)",
  "version": "0.1.1",
  "description": "Live FDA medical device safety and regulatory data: 510(k) and PMA decisions, device (and drug/food) recalls and enforcement reports, MAUDE device adverse event reports (and FAERS / CAERS via the same tool) with counts by year, event type or manufacturer, generic openFDA field counts, and the GUDID device identifier database (AccessGUDID lookup by UDI/DI; search by brand, company, product code or GMDN term). openFDA and AccessGUDID, no key.",
  "healthmesh_domain": "Medical Devices & Product Safety",
  "datasets": [
    "DEV-01"
  ],
  "mcp_endpoint": "https://device-safety.healthmesh.ai/mcp",
  "transport": "Streamable HTTP (stateless, JSON responses)",
  "authorization": "none",
  "auth_mode": "off",
  "docs": "https://github.com/HendrikK/healthmesh/tree/main/servers/device-safety-mcp#readme",
  "contact": "hendrik.kleine@gmail.com",
  "data_source": {
    "name": "openFDA (U.S. FDA) + AccessGUDID (NLM/FDA)",
    "url": "https://open.fda.gov/apis/device/",
    "license": "U.S. Government data, public domain (openFDA CC0 terms); no key; not for medical decision-making",
    "refresh": "live (12 h edge cache; openFDA weekly to monthly per endpoint)"
  },
  "tools": [
    {
      "name": "openfda_search_device_clearances",
      "title": "Search FDA 510(k) clearances and PMA approvals",
      "description": "Searches FDA premarket device decisions: 510(k) clearances (incl. De Novo grants, decision_code DENG) or PMA approvals and supplements, by product code, applicant, device name and decision date. Returns K/P number, applicant, device name, product code, decision date and description, and (510(k)) clearance type and third-party review flag."
    },
    {
      "name": "openfda_search_recalls",
      "title": "Search FDA recalls and enforcement reports",
      "description": "Searches FDA recall enforcement reports for devices, drugs or food (classification Class I/II/III, firm, reason, status, dates), or the device-only recall database (product code, root cause, K numbers)."
    },
    {
      "name": "openfda_search_adverse_events",
      "title": "Search MAUDE / FAERS adverse event reports",
      "description": "Searches adverse event reports: device (MAUDE medical device reports) by product code, brand or generic name, manufacturer, event type and date received, with optional narrative text; or drug (FAERS) / food (CAERS) reports via a raw openFDA search. Use maude_count_events or openfda_count_values for counts."
    },
    {
      "name": "openfda_count_values",
      "title": "Count openFDA records by a field",
      "description": "Counts openFDA records grouped by any field (openFDA count=), with an optional search, for any device/drug/food endpoint, e.g. device recalls by classification, MAUDE reports by device.manufacturer_d_name.exact, FAERS reactions by patient.reaction.reactionmeddrapt.exact."
    },
    {
      "name": "maude_count_events",
      "title": "Count MAUDE device reports",
      "description": "Counts MAUDE medical device reports grouped by year received, event type (death, injury, malfunction, other) or manufacturer, filtered by product code, brand name, event type, year range and narrative text (live openFDA device event data, 1991 onward)."
    },
    {
      "name": "gudid_lookup_device",
      "title": "Look up a device in AccessGUDID",
      "description": "Looks up a device by full UDI or device identifier (DI, e.g. GS1 GTIN-14) in AccessGUDID: brand, version/model, company, description, GMDN terms, FDA product codes, MRI safety status, sterility, Rx/OTC, single use, latex, premarket submissions and commercial distribution status."
    },
    {
      "name": "gudid_search_devices",
      "title": "Search GUDID devices",
      "description": "Searches GUDID device records (openFDA device/udi, refreshed weekly) by brand name, company, FDA product code or GMDN term. Returns primary DI, brand, model, company, product codes, GMDN terms, MRI safety and distribution status."
    },
    {
      "name": "device_describe_dataset",
      "title": "Describe the device safety sources",
      "description": "Explains the sources (openFDA device 510(k), PMA, recall, enforcement, event (MAUDE), UDI; drug/food enforcement and events; AccessGUDID), their refresh dates (live), coverage and caveats."
    }
  ]
}