# FDA Medical Device Establishment Registration Scraper (`automation-lab/fda-device-registration-scraper`) Actor Export FDA device establishment registrations, FEI numbers, owner/operators, addresses, product codes, classes, and 510(k)/PMA refs from openFDA. - **URL**: https://apify.com/automation-lab/fda-device-registration-scraper.md - **Developed by:** [Stas Persiianenko](https://apify.com/automation-lab) (community) - **Categories:** Business - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing Pay per event This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events. Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours, and optionally produces a well-defined JSON output, datasets with results, or files in key-value store. In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server. Actors are written with capital "A". ## How to integrate an Actor? If asked about integration, you help developers integrate Actors into their projects. You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ## FDA Medical Device Establishment Registration Scraper Export FDA medical device establishment registration records from the official openFDA API. Use this actor to collect firm names, FEI numbers, registration numbers, owner/operator data, addresses, product codes, device classes, medical specialties, and 510(k)/PMA references for compliance and market-intelligence workflows. ### What does FDA Medical Device Establishment Registration Scraper do? This actor searches the public openFDA `device/registrationlisting` endpoint and turns nested FDA registration records into clean dataset rows. Each output row represents one establishment registration and product-code combination. The actor is designed for repeatable exports, vendor qualification, supplier checks, and regulated-market mapping. It does not scrape a browser page. It uses the official openFDA JSON API. ### Who is it for? Medical-device compliance teams use it to verify registered establishments. Supplier qualification teams use it to enrich vendor profiles with FEI and registration data. KYB and due-diligence teams use it to check regulated manufacturers and importers. Regulatory intelligence teams use it to map products, device classes, and market participants. Data teams use it to automate recurring FDA establishment exports. ### Why use this actor? ✅ Official FDA source through openFDA. ✅ No login required for normal public queries. ✅ Output is normalized into one row per registration/product combination. ✅ Includes raw source records for audit trails. ✅ Supports structured filters and advanced raw openFDA syntax. ✅ Works well in scheduled Apify tasks. ### Data you can extract | Field group | Example fields | | --- | --- | | Registration identity | registrationNumber, feiNumber, statusCode, registrationExpiryYear | | Firm details | firmName, ownerOperatorName, ownerOperatorNumber | | Address | addressLine1, city, stateCode, countryCode, zipCode | | Establishment context | establishmentTypes, proprietaryNames, initialImporterFlag | | Product data | productCode, deviceName, medicalSpecialty, deviceClass | | FDA references | regulationNumber, kNumber, pmaNumber | | Audit metadata | openFdaQuery, sourceUrl, scrapedAt, rawRecord | ### How much does it cost to scrape FDA device registrations? This actor uses pay-per-event pricing. There is a $0.005 start fee per run and a tiered per-item charge for each saved dataset row. Current BRONZE item price is $0.000026751 per FDA registration/product row, with FREE $0.000030763, SILVER $0.000020865, GOLD $0.00001605, PLATINUM $0.0000107, and DIAMOND $0.00001. The default input is intentionally small so first runs stay inexpensive. For high-volume exports, use `maxItems` to control spend. The final platform pricing is shown on the Apify actor page before you start a run. ### Input options `firmName` searches FDA registration firm names and owner/operator firm names. `feiNumber` finds a specific FDA Facility Establishment Identifier. `registrationNumber` finds a specific device establishment registration. `countryCode` filters by ISO country code such as `US`, `DE`, or `CN`. `stateCode` filters US establishments by state. `productCode` filters by FDA medical device product code. `ownerOperator` searches the owner/operator firm name. `rawQuery` lets advanced users provide openFDA search syntax directly. `maxItems` limits saved dataset rows. ### Example input: company search ```json { "firmName": "Medtronic", "maxItems": 100 } ```` ### Example input: US product-code search ```json { "countryCode": "US", "productCode": "MNI", "maxItems": 250 } ``` ### Example input: exact registration lookup ```json { "registrationNumber": "1030489", "maxItems": 25 } ``` ### Example input: raw openFDA query ```json { "rawQuery": "registration.iso_country_code:\"US\" AND products.product_code:\"MNI\"", "maxItems": 100 } ``` ### Output example ```json { "registrationNumber": "1030489", "feiNumber": "1000477302", "firmName": "MEDTRONIC SOFAMOR DANEK USA, INC.", "ownerOperatorName": "Medtronic, Inc.", "countryCode": "US", "stateCode": "TN", "city": "Memphis", "productCode": "MNI", "deviceName": "Orthosis, Spinal Pedicle Fixation", "deviceClass": "2", "medicalSpecialty": "Orthopedic", "registrationExpiryYear": "2026", "kNumber": "K062447", "pmaNumber": null } ``` ### How to run it 1. Open the actor on Apify. 2. Enter a firm name, FEI number, product code, geography filter, or raw openFDA query. 3. Set `maxItems` to the number of rows you need. 4. Start the actor. 5. Download results as JSON, CSV, Excel, XML, or HTML from the dataset. ### Search tips Use `firmName` for broad company discovery. Use `registrationNumber` or `feiNumber` for exact entity checks. Use `countryCode` plus `productCode` for market mapping. Use `ownerOperator` when a brand has many registered facilities. Use `rawQuery` only if you already know openFDA search syntax. Keep initial tests small, then increase `maxItems` after verifying the query. ### Rate limits and pagination The actor paginates openFDA responses with `limit` and `skip`. If openFDA returns HTTP 429, the actor backs off and retries. The actor stops when it reaches `maxItems`, when openFDA has no more results, or when openFDA skip limits are reached. For recurring large exports, schedule smaller focused tasks instead of one very broad run. ### Integrations Send supplier records into a compliance warehouse. Enrich CRM accounts with FDA registration identifiers. Monitor a product code for new or changed registered establishments. Export country-specific manufacturer lists for distributor due diligence. Join output with adverse-event or recall datasets in downstream analytics. ### API usage with Node.js ```js import { ApifyClient } from 'apify-client'; const client = new ApifyClient({ token: process.env.APIFY_TOKEN }); const run = await client.actor('automation-lab/fda-device-registration-scraper').call({ firmName: 'Medtronic', maxItems: 100, }); console.log(run.defaultDatasetId); ``` ### API usage with Python ```python from apify_client import ApifyClient client = ApifyClient('YOUR_APIFY_TOKEN') run = client.actor('automation-lab/fda-device-registration-scraper').call( run_input={'firmName': 'Medtronic', 'maxItems': 100} ) print(run['defaultDatasetId']) ``` ### API usage with cURL ```bash curl -X POST 'https://api.apify.com/v2/acts/automation-lab~fda-device-registration-scraper/runs?token=YOUR_APIFY_TOKEN' \ -H 'Content-Type: application/json' \ -d '{"firmName":"Medtronic","maxItems":100}' ``` ### MCP for Claude Code and Claude Desktop You can call this actor through Apify MCP. Use the actor-specific MCP URL so Claude sees the right tool: ```text https://mcp.apify.com/?tools=automation-lab/fda-device-registration-scraper ``` Add it in Claude Code: ```bash claude mcp add apify-fda-device-registrations https://mcp.apify.com/?tools=automation-lab/fda-device-registration-scraper ``` Or add this MCP server JSON configuration in Claude Desktop: ```json { "mcpServers": { "apify-fda-device-registrations": { "url": "https://mcp.apify.com/?tools=automation-lab/fda-device-registration-scraper" } } } ``` Example prompts: - "Find FDA device registrations for Medtronic and summarize the product codes." - "Export US establishments for product code MNI and group them by state." - "Check whether this supplier has an FDA FEI number and registered device products." ### Data quality notes The output reflects openFDA source data at run time. FDA names are often uppercase and may use legal entity names. Some records have multiple products, so one registration can produce multiple rows. Some optional fields may be empty in the FDA source. Use `rawRecord` when you need the unmodified source object. ### Legality This actor uses public FDA data served by the official openFDA API. You are responsible for using the data in compliance with applicable laws, FDA terms, openFDA API rules, and your internal regulatory policies. Do not treat this dataset as legal advice or a substitute for regulatory review. ### Troubleshooting If you get no results, try a shorter firm name or an exact FEI number. If a raw query fails, test the same syntax in openFDA documentation and escape quotes correctly in JSON. If a run stops before your desired volume, narrow the query or reduce `maxItems` to stay within openFDA pagination constraints. If product data looks duplicated, remember the actor emits one row per registration/product combination. ### FAQ #### Does this actor require an FDA API key? No. The actor works with public openFDA access for normal queries. #### Does it scrape FDA web pages? No. It calls the official openFDA JSON API. #### Can I search by product code? Yes. Use `productCode`, for example `MNI`. #### Can I search by FEI number? Yes. Use `feiNumber` for exact FEI lookups. #### Why are there multiple rows for the same registration? One FDA registration can list multiple products. The actor creates separate rows so each product code is easy to filter and export. ### Related scrapers - FDA MAUDE Adverse Event Reports Scraper: https://apify.com/automation-lab/fda-maude-adverse-event-reports-scraper - Use this actor for establishment registration and product listings. - Use adverse-event or recall actors when your workflow is safety surveillance rather than establishment qualification. ### Changelog Initial version: openFDA device registration listing export with structured and raw query inputs. ### Support If a query does not return the FDA records you expect, include your input JSON, expected firm/product, and a sample FDA record in the issue report. ### More examples Search for a non-US supplier by country code. Search a parent owner/operator across multiple facilities. Build a scheduled task for a product code and compare exports month over month. Use the dataset API to pull fresh rows into Snowflake, BigQuery, Airtable, or a compliance dashboard. ### Field reference `registrationNumber` is the FDA registration number. `feiNumber` is the Facility Establishment Identifier. `firmName` is the registered establishment name. `ownerOperatorName` is the owner/operator firm reported by FDA. `statusCode` is the FDA status code from the source. `registrationExpiryYear` is the registration expiry year. `productCode` is the FDA product code. `deviceClass` is the openFDA device class where available. `rawRecord` contains the original FDA JSON record for audits. # Actor input Schema ## `firmName` (type: `string`): Searches FDA registration firm name and owner/operator firm name. Example: Medtronic, Boston Scientific, Philips. ## `feiNumber` (type: `string`): FDA Facility Establishment Identifier (FEI) number. Leave empty unless you need an exact facility. ## `registrationNumber` (type: `string`): FDA medical device establishment registration number. ## `countryCode` (type: `string`): Two-letter ISO country code, for example US, DE, CN, IE, MX. ## `stateCode` (type: `string`): Two-letter state code for US establishments, for example TN, MN, CA. ## `productCode` (type: `string`): Medical device product code such as MNI. The actor outputs one row per registration/product combination. ## `ownerOperator` (type: `string`): Search the FDA owner/operator firm name. ## `rawQuery` (type: `string`): Advanced users can provide an openFDA search query. When set, it overrides all structured filters. Example: registration.iso\_country\_code:"US" AND products.product\_code:"MNI". ## `maxItems` (type: `integer`): Maximum dataset rows to emit. Rows are registration/product combinations, so one establishment can produce multiple rows. ## Actor input object example ```json { "firmName": "Medtronic", "maxItems": 20 } ``` # Actor output Schema ## `overview` (type: `string`): No description # API You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup. ## JavaScript example ```javascript import { ApifyClient } from 'apify-client'; // Initialize the ApifyClient with your Apify API token // Replace the '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "firmName": "Medtronic", "maxItems": 20 }; // Run the Actor and wait for it to finish const run = await client.actor("automation-lab/fda-device-registration-scraper").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`); const { items } = await client.dataset(run.defaultDatasetId).listItems(); items.forEach((item) => { console.dir(item); }); // 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs ``` ## Python example ```python from apify_client import ApifyClient # Initialize the ApifyClient with your Apify API token # Replace '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "firmName": "Medtronic", "maxItems": 20, } # Run the Actor and wait for it to finish run = client.actor("automation-lab/fda-device-registration-scraper").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "firmName": "Medtronic", "maxItems": 20 }' | apify call automation-lab/fda-device-registration-scraper --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=automation-lab/fda-device-registration-scraper", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Medical Device Establishment Registration Scraper", "description": "Export FDA device establishment registrations, FEI numbers, owner/operators, addresses, product codes, classes, and 510(k)/PMA refs from openFDA.", "version": "0.1", "x-build-id": "si5OVH3dmvPekebDh" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/automation-lab~fda-device-registration-scraper/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-automation-lab-fda-device-registration-scraper", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/automation-lab~fda-device-registration-scraper/runs": { "post": { "operationId": "runs-sync-automation-lab-fda-device-registration-scraper", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/automation-lab~fda-device-registration-scraper/run-sync": { "post": { "operationId": "run-sync-automation-lab-fda-device-registration-scraper", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "properties": { "firmName": { "title": "Firm or establishment name", "type": "string", "description": "Searches FDA registration firm name and owner/operator firm name. Example: Medtronic, Boston Scientific, Philips." }, "feiNumber": { "title": "FEI number", "type": "string", "description": "FDA Facility Establishment Identifier (FEI) number. Leave empty unless you need an exact facility." }, "registrationNumber": { "title": "Registration number", "type": "string", "description": "FDA medical device establishment registration number." }, "countryCode": { "title": "Country code", "type": "string", "description": "Two-letter ISO country code, for example US, DE, CN, IE, MX." }, "stateCode": { "title": "US state code", "type": "string", "description": "Two-letter state code for US establishments, for example TN, MN, CA." }, "productCode": { "title": "FDA product code", "type": "string", "description": "Medical device product code such as MNI. The actor outputs one row per registration/product combination." }, "ownerOperator": { "title": "Owner/operator name", "type": "string", "description": "Search the FDA owner/operator firm name." }, "rawQuery": { "title": "Raw openFDA search query", "type": "string", "description": "Advanced users can provide an openFDA search query. When set, it overrides all structured filters. Example: registration.iso_country_code:\"US\" AND products.product_code:\"MNI\"." }, "maxItems": { "title": "Maximum rows", "minimum": 1, "maximum": 10000, "type": "integer", "description": "Maximum dataset rows to emit. Rows are registration/product combinations, so one establishment can produce multiple rows.", "default": 20 } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```