openFDA
api.fda.gov
FDA drug, device and food data: adverse events, recalls, labels and registrations.
GET /v1/data/openfda/device510k1Request
openFDA Lucene query, e.g. `field:"value"`. Combine with `+AND+` / `+OR+`. Omit to match everything.
Field to tally instead of returning records, e.g. `applicant.exact` or `advisory_committee_description.exact`.
curl "https://api.fastcrw.com/v1/data/openfda/device510k?limit=10&skip=0" \ -H "Authorization: Bearer $FASTCRW_API_KEY"
2Response example
A sample shape. Press Run to see live data from openFDA.
{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-10-12",
"results": {
"skip": 0,
"limit": 10,
"total": 176415
}
},
"results": [
{
"third_party_flag": "N",
"city": "Mchenry",
"advisory_committee_description": "Hematology",
"address_1": "803 N. Front St. Suite 3",
"address_2": "",
"statement_or_summary": "",
"product_code": "KIS",
"openfda": {
"registration_number": [
"9710594",
"3017716384",
"… 4 more items"
],
"fei_number": [
"3017716384",
"1000119228",
"… 4 more items"
],
"device_name": "Sera, Animal And Human",
"medical_specialty_description": "Hematology",
"regulation_number": "864.2800",
"device_class": "1"
},
"zip_code": "60050",
"applicant": "Dutchland Laboratories, Inc.",
"decision_date": "1981-09-08",
"decision_code": "SESE",
"country_code": "US",
"device_name": "GUINEA PIG SERUM - STERILE",
"advisory_committee": "HE",
"contact": "",
"expedited_review_flag": "",
"k_number": "K812379",
"state": "IL",
"date_received": "1981-08-20",
"review_advisory_committee": "PA",
"postal_code": "60050",
"decision_description": "Substantially Equivalent",
"clearance_type": "Traditional"
},
{
"third_party_flag": "N",
"city": "Mchenry",
"advisory_committee_description": "Anesthesiology",
"address_1": "803 N. Front St. Suite 3",
"address_2": "",
"statement_or_summary": "",
"product_code": "CAF",
"openfda": {
"registration_number": [
"3015058854",
"3043460907",
"… 190 more items"
],
"fei_number": [
"3015058854",
"3043460907",
"… 190 more items"
],
"device_name": "Nebulizer (Direct Patient Interface)",
"medical_specialty_description": "Anesthesiology",
"regulation_number": "868.5630",
"device_class": "2"
},
"zip_code": "60050",
"applicant": "Aerway Laboratories, Inc.",
"decision_date": "1976-08-26",
"decision_code": "SESE",
"country_code": "US",
"device_name": "NEBULIZER ADAPTER (AERMIST)",
"advisory_committee": "AN",
"contact": "",
"expedited_review_flag": "",
"k_number": "K760442",
"state": "IL",
"date_received": "1976-08-16",
"review_advisory_committee": "AN",
"postal_code": "60050",
"decision_description": "Substantially Equivalent",
"clearance_type": "Traditional"
},
"… 8 more items"
]
}Attribution: Source: openFDA, U.S. Food and Drug Administration
Licence: A work of the United States Government, not subject to domestic copyright under 17 U.S.C. 105, published by the agency as open data. openFDA adds its own terms: the data is not for clinical decisions and you may not imply FDA endorsement.
Ask with this source
A prompt for your agent that names this source and how to call it through the crw MCP.
510(k) clearances
Use openFDA (openfda) from fastCRW Pergamon, capability "510(k) clearances" (device510k). You want to know when a device was cleared for US market, under which K number, or what a company has cleared. Example options: search=device_name:"catheter", count=applicant.exact, limit=10. Use the crw MCP tools: crw_find_data to confirm the source and its options, then crw_get_data with provider "openfda" and capability "device510k". Tell me the credits used and cite the licence from the response. If the crw MCP tools are missing, install them with: npx -y crw-mcp install --api-key <your fastCRW API key>
Device classification
Use openFDA (openfda) from fastCRW Pergamon, capability "Device classification" (deviceclass). You need a device's regulatory class, product code or CFR regulation number before looking anything else up. Example options: search=device_name:"stent", count=medical_specialty_description.exact, limit=10. Use the crw MCP tools: crw_find_data to confirm the source and its options, then crw_get_data with provider "openfda" and capability "deviceclass". Tell me the credits used and cite the licence from the response. If the crw MCP tools are missing, install them with: npx -y crw-mcp install --api-key <your fastCRW API key>
Device adverse event reports (MAUDE)
Use openFDA (openfda) from fastCRW Pergamon, capability "Device adverse event reports (MAUDE)" (deviceevent). You want reported failures or harms involving a medical device. Example options: search=device.generic_name:"insulin pump", count=device.brand_name.exact, limit=5. Use the crw MCP tools: crw_find_data to confirm the source and its options, then crw_get_data with provider "openfda" and capability "deviceevent". Tell me the credits used and cite the licence from the response. If the crw MCP tools are missing, install them with: npx -y crw-mcp install --api-key <your fastCRW API key>
Medical device recalls and enforcement
Use openFDA (openfda) from fastCRW Pergamon, capability "Medical device recalls and enforcement" (devicerecall). You want recall history for a medical device or manufacturer. Example options: search=classification:"Class I", count=state.exact, limit=10. Use the crw MCP tools: crw_find_data to confirm the source and its options, then crw_get_data with provider "openfda" and capability "devicerecall". Tell me the credits used and cite the licence from the response. If the crw MCP tools are missing, install them with: npx -y crw-mcp install --api-key <your fastCRW API key>