FDA Medical Device Establishment Registration Scraper

Extract structured establishment and manufacturer data from the openFDA Device Registration & Listing database — the authoritative source for FDA-registered medical device manufacturers, importers, and contract manufacturers. This Actor fetches device establishment registrations and provides powerful filtering by state, country, firm name, and product code.

The openFDA Device Registration & Listing data is maintained by the U.S. Food and Drug Administration (FDA) as the official registry of all establishments that manufacture, import, or contract-manufacture medical devices for the U.S. market. Regulatory professionals, quality assurance teams, procurement specialists, and business development professionals rely on this data for supply chain verification, competitive intelligence, and product sourcing.

Key Features

• Complete device establishment registration extraction — Access FDA-registered manufacturers, importers, repackagers, and distributors
• State filtering — Narrow results to specific US states (e.g., "CA", "TX", "NY")
• Country filtering — Filter by ISO country codes (e.g., "US", "DE", "JP")
• Firm name search — Case-insensitive partial matching on establishment names
• Product code filtering — Isolate establishments by FDA device classification product codes (e.g., "MQP", "LLL")
• Comprehensive product data — Extract product codes, device names, medical specialty classifications, and regulatory information
• Contact information — Owner/operator firm names and regulatory correspondent contact details
• No authentication required — Free public openFDA API, no credentials needed
• Batch-optimized output — Clean JSON ready for supply chain analysis, RAG pipelines, or business intelligence platforms

Output Data Fields

Field	Type	Description
firmName	string	Establishment name (manufacturer, importer, etc.)
registrationNumber	string	FDA registration number for this establishment
feiNumber	string	Facility Establishment Identifier (FEI) number
establishmentType	string	Establishment type(s), e.g., "Manufacturer; Importer"
addressLine1	string	Street address (line 1)
addressLine2	string	Street address (line 2, if applicable)
city	string	City name
stateCode	string	US state code (2-letter) or province
countryCode	string	ISO 3166-1 country code
zipCode	string	Postal code / ZIP code
ownerOperatorFirm	string	Parent company or owner operator firm name
correspondentName	string	Regulatory correspondent (official contact) name
correspondentPhone	string	Regulatory correspondent phone number
proprietaryNames	string	Proprietary product names (brand names)
productCodes	string	Comma-separated FDA device product codes (e.g., "MQP, LLL, OPN")
deviceNames	string	Device classification names (e.g., "Infusion pump", "X-ray tube")
medicalSpecialties	string	Medical specialty descriptions (e.g., "General and Plastic Surgery", "Orthopedic")
registrationExpiryYear	string	Registration expiry year (YYYY)

How to Scrape FDA Device Manufacturer Registrations

Step-by-Step Tutorial

1. Navigate to the Actor — Open the FDA Medical Device Establishment Registration Scraper on the Apify Store.

2. Start the Run — Click Start to open the input configuration form.

3. (Optional) Filter by State — Enter a 2-letter US state code (e.g., "CA", "TX") to narrow results to a specific state. Leave blank to include all states.

4. (Optional) Filter by Country — Enter an ISO country code (e.g., "US", "DE") to filter by manufacturing location. Leave blank for all countries.

5. (Optional) Search by Firm Name — Enter a firm name or partial match (e.g., "Boston Scientific", "Abbott") to find specific manufacturers. The search is case-insensitive.

6. (Optional) Filter by Product Code — Enter an FDA device product code (e.g., "MQP" for infusion pumps) to isolate establishments manufacturing specific device types. Leave blank to include all product codes.

7. Set Max Results — Choose the maximum number of registrations to return (default: 1000, max: 25,000). Set to 0 for unlimited results.

8. Click Start — Launch the scraping run.

9. Download Results — After the run completes, download results as JSON, CSV, or Excel from the Dataset tab.

Example Scenarios

• Supply Chain Mapping — Search for all manufacturers in "CA" to map your device supply chain in California.
• Competitive Intelligence — Search by firm name ("Medtronic") to find all their registered establishments and their product portfolios.
• Product Sourcing — Filter by product code ("MQP") to find all manufacturers of infusion pumps in a specific country.
• Regulatory Compliance — Extract all establishments in your state to audit supplier compliance and certification status.
• Market Research — Download all US-based device manufacturers to analyze market concentration, ownership structure, and product diversity.

Input Example

{
    "stateCode": "CA",
    "countryCode": "US",
    "firmName": "Boston Scientific",
    "productCode": "",
    "maxResults": 100
}

Output Example

{
    "firmName": "Boston Scientific Corporation",
    "registrationNumber": "1234567",
    "feiNumber": "1234567890",
    "establishmentType": "Manufacturer; Importer",
    "addressLine1": "123 Main Street",
    "addressLine2": "",
    "city": "San Jose",
    "stateCode": "CA",
    "countryCode": "US",
    "zipCode": "95110",
    "ownerOperatorFirm": "Boston Scientific Corporation",
    "correspondentName": "John Smith",
    "correspondentPhone": "408-555-1234",
    "proprietaryNames": "Innervention; CODA; Apex",
    "productCodes": "MQP, LLL, OPN",
    "deviceNames": "Infusion pump; Drainage catheter; Ligation clip",
    "medicalSpecialties": "Cardiovascular; Surgery; Urology",
    "registrationExpiryYear": "2027"
}

Pricing

This Actor fetches data from the free openFDA public API. Computation costs are low as data is retrieved via paginated HTTP requests.

• Cost per run: ~$0.001-0.002 (API pagination, no browser required)
• Actor start event: Default platform rate
• Per-result pricing: $0.003/result

Typical run time for 1,000 results is under 30 seconds.

Use Cases

• Supply Chain Intelligence — Build a database of all device manufacturers by geography, product type, and ownership structure
• Regulatory Compliance — Audit supplier registrations, verify FEI numbers, and track registration expiry dates
• Competitive Market Analysis — Identify all competitors manufacturing specific device types in your target markets
• Product Sourcing & Procurement — Find qualified manufacturers for device component outsourcing and contract manufacturing
• Regulatory Correspondent Research — Extract official FDA contact information for regulatory communications
• Business Development — Prospect potential acquisition targets or partnership opportunities in specific device categories
• RAG Pipeline Ingestion — Clean structured output ready for LLM-based supply chain analysis or regulatory intelligence

FAQ

Q: What is the difference between registrations and listings? A: The FDA Device Registration & Listing system captures establishment registrations (the facilities) and their product listings (the specific devices manufactured at those facilities). This Actor extracts registrations with their associated product data.

Q: Can I filter by multiple criteria at once? A: Yes. You can combine state, country, firm name, and product code filters in a single run. The Actor applies API-level search (for firm name and product code) and client-side filtering (for state and country).

Q: What if a firm has multiple establishments? A: Each establishment appears as a separate record. You may see multiple registrations from the same firm if they operate multiple facilities.

Q: Are imports/importers included? A: Yes. The establishmentType field indicates whether an establishment is a manufacturer, importer, repackager, distributer, or combination thereof.

Q: How often is the openFDA data updated? A: The FDA updates device registration data continuously as new establishments register and existing registrations change. The Actor retrieves the latest data from the live openFDA API.

Q: What does "ISO country code" mean? A: ISO 3166-1 is the international standard for country codes. US = United States, DE = Germany, JP = Japan, etc. Use a 2-letter code.

Legal Disclaimer

This Actor extracts publicly available data from the U.S. FDA's openFDA database. All data is in the public domain. This Actor is for informational and research purposes only. Users are responsible for compliance with applicable laws and regulations regarding the use of medical device manufacturer data. Always verify data accuracy and current registration status with the FDA directly before making regulatory or business decisions.

Support

For issues, questions, or feature requests, please contact the Actor author or visit the Apify community forum.