FDA Registered Medical Device Establishments Scraper

Build a clean, structured directory of medical device companies registered with the U.S. FDA — manufacturers, contract manufacturers, specification developers, sterilizers, repackagers, importers and foreign exporters to the United States. Every record ties a registered establishment to its owner/operator company, its regulatory contacts and the exact devices it lists.

Ideal for KYB and supplier due diligence, sales prospecting into the medical device industry, competitive and market mapping, regulatory monitoring, and building a MedTech company database.

What you get (per establishment)

Establishment identity

• Establishment name
• FDA registration number and FEI number
• Establishment type(s): manufacturer, contract manufacturer, specification developer, contract sterilizer, repackager/relabeler, initial importer, foreign exporter, reprocessor and more
• Registration status and expiry year
• Initial-importer flag

Full address

• Street, city, state, ZIP / postal code, ISO country

Owner / operator (the parent company behind the facility)

• Owner/operator firm name and number
• Official correspondent name and phone
• Owner/operator contact address

U.S. agent (the U.S. point of contact for foreign establishments)

• Agent name and business name
• Email address
• Phone and fax
• Agent mailing address

Devices the establishment lists

• FDA product codes
• Device names and medical specialties
• Device risk class (I / II / III)
• Regulation numbers
• Linked 510(k) and PMA numbers, proprietary/brand names

Filters

• Company name — matches establishment name or owner/operator firm
• FDA product code — one or many (e.g. LLZ, DXN)
• Device name keyword — e.g. catheter, stent, ventilator
• Establishment type — manufacturer, contract manufacturer, sterilizer, importer, etc.
• Device class — I, II or III
• Country — 2-letter ISO (US, DE, CN, JP, …)
• U.S. state — 2-letter code
• Initial importers only
• Free-text / field search for advanced queries
• Max records cap

Example input

{
  "country": "DE",
  "establishmentType": "Manufacture Medical Device",
  "deviceName": "catheter",
  "maxRecords": 500
}

Example output

{
  "establishmentName": "PTUMEDICAL GMBH",
  "registrationNumber": "3016237080",
  "feiNumber": "3016237080",
  "establishmentTypes": ["Manufacture Medical Device for Another Party (Contract Manufacturer)"],
  "city": "Spaichingen",
  "country": "DE",
  "ownerOperatorFirm": "PTUmedical GmbH",
  "officialCorrespondent": "Tevfik Uzun",
  "officialCorrespondentPhone": "497424609370",
  "usAgentName": "Franz Menean",
  "usAgentEmail": "mail@medagent-usa.com",
  "usAgentPhone": "6035702039",
  "usAgentCity": "Portsmouth",
  "usAgentState": "NH",
  "productCodes": ["OVE"],
  "deviceNames": ["Intervertebral Fusion Device With Integrated Fixation, Cervical"],
  "deviceClasses": ["2"],
  "medicalSpecialties": ["Orthopedic"],
  "kNumber": null,
  "pmaNumber": null,
  "observedAt": "2026-08-14T21:07:03.299Z"
}

Output formats

Export to JSON, CSV, Excel, or via API for direct import into your CRM, data warehouse or enrichment pipeline.

Notes

• Data reflects official public U.S. FDA device establishment registration and listing records.
• Very large pulls are best narrowed by country, state or product code.
• Free Apify plans are capped at 10 records per run.