openFDA
openFDA Device API

Device-domain endpoints covering MAUDE adverse event reports, device classification, 510(k) premarket notifications, PMA premarket approvals, UDI Unique Device Identifier records, device recall enforcement reports, device recalls, registration and listing, and the COVID-19 in vitro diagnostic serology test results dataset.
openFDA Device API is one of 6 APIs that openFDA publishes on the APIs.io network, described by a machine-readable OpenAPI specification.
This API exposes 1 machine-runnable capability that can be deployed as REST, MCP, or Agent Skill surfaces via Naftiko.
Tagged areas include Device, Adverse Events, 510(k), PMA, and UDI. The published artifact set on APIs.io includes API documentation, an OpenAPI specification, and 1 Naftiko capability spec.
Documentation GitHub OpenAPI
OpenAPI Specification

openapi: 3.0.3
info:
  title: openFDA API
  description: >-
    openFDA is an Elasticsearch-based public API serving FDA data on drugs,
    devices, foods, animal/veterinary products, and tobacco. Each noun exposes
    one or more categories (adverse events, recall enforcement reports,
    labeling, classification, registration, etc.).
  version: "1.0"
  contact:
    name: openFDA
    url: https://open.fda.gov/apis
    email: [email protected]
  license:
    name: CC0 1.0 Universal (Public Domain Dedication)
    url: https://creativecommons.org/publicdomain/zero/1.0/
servers:
  - url: https://api.fda.gov
    description: openFDA production API
security:
  - apiKeyQuery: []
  - {}
tags:
  - name: Drug
    description: Drug-related endpoints (adverse events, labeling, recalls, NDC).
  - name: Device
    description: Device-related endpoints (adverse events, classifications, recalls, 510(k), PMA, UDI).
  - name: Food
    description: Food-related endpoints (enforcement reports, adverse events).
  - name: Animal & Veterinary
    description: Adverse events involving animal and veterinary products.
  - name: Tobacco
    description: Tobacco product problem reports.
  - name: Other
    description: Cross-cutting datasets (NSDE, substance, harmonized).
paths:
  /drug/event.json:
    get:
      tags: [Drug]
      summary: Drug adverse events (FAERS)
      description: Query the FDA Adverse Event Reporting System (FAERS) for drug adverse event reports submitted since 2004.
      operationId: searchDrugEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
        '404':
          $ref: '#/components/responses/NotFound'
        '429':
          $ref: '#/components/responses/RateLimited'
  /drug/label.json:
    get:
      tags: [Drug]
      summary: Drug product labeling (SPL)
      description: Query Structured Product Labeling (SPL) records for prescription and over-the-counter drugs.
      operationId: searchDrugLabel
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/enforcement.json:
    get:
      tags: [Drug]
      summary: Drug recall enforcement reports
      description: Query drug recall enforcement reports from the FDA Recall Enterprise System (RES).
      operationId: searchDrugEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/ndc.json:
    get:
      tags: [Drug]
      summary: NDC Directory
      description: Query the National Drug Code (NDC) Directory of products in commercial distribution.
      operationId: searchDrugNDC
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/drugsfda.json:
    get:
      tags: [Drug]
      summary: Drugs@FDA
      description: Query Drugs@FDA approval records including applications, submissions, and products.
      operationId: searchDrugsFDA
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /drug/shortages.json:
    get:
      tags: [Drug]
      summary: Drug shortages
      description: Query the FDA drug shortage database.
      operationId: searchDrugShortages
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/event.json:
    get:
      tags: [Device]
      summary: Device adverse events (MAUDE)
      description: Query the Manufacturer and User Facility Device Experience (MAUDE) database for medical device adverse event reports.
      operationId: searchDeviceEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/enforcement.json:
    get:
      tags: [Device]
      summary: Device recall enforcement reports
      operationId: searchDeviceEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/recall.json:
    get:
      tags: [Device]
      summary: Device recalls
      operationId: searchDeviceRecalls
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/classification.json:
    get:
      tags: [Device]
      summary: Device product classifications
      operationId: searchDeviceClassification
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/510k.json:
    get:
      tags: [Device]
      summary: 510(k) clearances
      operationId: searchDevice510k
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/pma.json:
    get:
      tags: [Device]
      summary: Premarket Approval (PMA) records
      operationId: searchDevicePMA
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/registrationlisting.json:
    get:
      tags: [Device]
      summary: Device registrations and listings
      operationId: searchDeviceRegistrationListing
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/udi.json:
    get:
      tags: [Device]
      summary: Unique Device Identifier (UDI) database
      operationId: searchDeviceUDI
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /device/covid19serology.json:
    get:
      tags: [Device]
      summary: COVID-19 serology testing data
      operationId: searchCovid19Serology
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /food/enforcement.json:
    get:
      tags: [Food]
      summary: Food recall enforcement reports
      description: Query food recall enforcement reports from the FDA Recall Enterprise System (RES). Updated weekly, data from 2004 onward.
      operationId: searchFoodEnforcement
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /food/event.json:
    get:
      tags: [Food]
      summary: Food adverse events (CAERS)
      description: Query the CFSAN Adverse Event Reporting System (CAERS) for adverse events associated with foods, dietary supplements, and cosmetics.
      operationId: searchFoodEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /animalandveterinary/event.json:
    get:
      tags: [Animal & Veterinary]
      summary: Animal & veterinary adverse events
      description: Query adverse events involving animal drugs and veterinary products.
      operationId: searchAnimalVetEvents
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /tobacco/problem.json:
    get:
      tags: [Tobacco]
      summary: Tobacco product problem reports
      operationId: searchTobaccoProblems
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/nsde.json:
    get:
      tags: [Other]
      summary: National Drug Code SPL Data Elements (NSDE)
      operationId: searchNSDE
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/substance.json:
    get:
      tags: [Other]
      summary: Substance data
      operationId: searchSubstance
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
  /other/historicaldocument.json:
    get:
      tags: [Other]
      summary: Historical FDA documents
      operationId: searchHistoricalDocuments
      parameters:
        - $ref: '#/components/parameters/Search'
        - $ref: '#/components/parameters/Sort'
        - $ref: '#/components/parameters/Count'
        - $ref: '#/components/parameters/Limit'
        - $ref: '#/components/parameters/Skip'
      responses:
        '200':
          $ref: '#/components/responses/SearchResults'
components:
  securitySchemes:
    apiKeyQuery:
      type: apiKey
      in: query
      name: api_key
      description: >-
        Free openFDA API key (obtain at https://open.fda.gov/apis/authentication/).
        Without a key: 240 req/min and 1,000 req/day per IP. With a key: 240
        req/min and 120,000 req/day per key.
  parameters:
    Search:
      name: search
      in: query
      description: Lucene-style search expression scoped to the dataset's fields.
      required: false
      schema:
        type: string
      example: receivedate:[2024-01-01+TO+2024-12-31]
    Sort:
      name: sort
      in: query
      description: Field to sort by, with optional direction (e.g. `receivedate:desc`).
      required: false
      schema:
        type: string
    Count:
      name: count
      in: query
      description: Field to count occurrences against (returns aggregated terms).
      required: false
      schema:
        type: string
    Limit:
      name: limit
      in: query
      description: Maximum number of records to return (max 1000).
      required: false
      schema:
        type: integer
        minimum: 1
        maximum: 1000
        default: 1
    Skip:
      name: skip
      in: query
      description: Number of records to skip for pagination (max 25,000).
      required: false
      schema:
        type: integer
        minimum: 0
        maximum: 25000
        default: 0
  responses:
    SearchResults:
      description: Successful query result.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/SearchResponse'
    NotFound:
      description: No matching records found.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/Error'
    RateLimited:
      description: Rate limit exceeded.
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/Error'
  schemas:
    Meta:
      type: object
      properties:
        disclaimer:
          type: string
        terms:
          type: string
          format: uri
        license:
          type: string
          format: uri
        last_updated:
          type: string
          format: date
        results:
          type: object
          properties:
            skip:
              type: integer
            limit:
              type: integer
            total:
              type: integer
    SearchResponse:
      type: object
      properties:
        meta:
          $ref: '#/components/schemas/Meta'
        results:
          type: array
          items:
            type: object
            additionalProperties: true
    Error:
      type: object
      properties:
        error:
          type: object
          properties:
            code:
              type: string
            message:
              type: string
openFDA Device API

Documentation

Specifications

Other Resources

OpenAPI Specification
