FDA Medical Device Establishment Leads | Business Leads

Build lead lists of medical device companies from FDA's establishment registration and device listing data. Filter by country, US state, establishment type (manufacturer, contract manufacturer, contract sterilizer, repackager/relabeler, specification developer and more), FDA product code, device class and medical specialty. You get one clean row per FDA-registered establishment, with its firm name, registration and FEI numbers, registered business address, owner/operator company, establishment types, product codes, device classes and specialties.

• 🏭 Find suppliers and prospects: contract manufacturers, sterilizers, relabelers and device makers, by state or country.
• 🎯 Filters: countries, states, establishment types, product codes, device class, medical specialty, company name.
• 🔒 Firm-level data only: no personal names, phone numbers or email addresses. Correspondent and US agent contacts are left out on purpose.
• 💲 $3.00 per 1,000 leads ($0.003 per row). No start fee. Empty and failed runs are free.

Data source: Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): the openFDA device registration & listing dataset, which openFDA publishes as public domain (CC0 1.0). Every row has a source credit and a sourceUrl link to the openFDA record.

Disclaimer: Not affiliated with, endorsed by or sponsored by the U.S. FDA. FDA registration and listing is not FDA approval or clearance of a firm or its devices. openFDA data is unvalidated. Confirm details in FDA's own Establishment Registration & Device Listing database (each row's fdaDatabaseUrl) before you rely on them.

What does it do?

1. It turns your filters into one query to the official openFDA API (no API key needed) and reads the matching device listing records, 1,000 per request, sorted by FDA registration number.
2. It merges each establishment's listings into one row per establishment, with product codes, device names, classes and specialties de-duplicated.
3. It stops as soon as it has Max results establishments, or when it reaches the maximum cost you set for the run.

In local tests on 2026-10-28, the default input (US contract manufacturers, 100 leads) took 1.0 to 1.6 seconds of Actor time with 1 openFDA request and about 76 MB of memory. All 2,202 US contract manufacturers took 12.5 seconds (26 requests). All 10,358 US establishments took 74 seconds (158 requests) and peaked at 111 MB.

Who is it for?

• Suppliers to device makers: components, packaging, sterilization, testing labs, software and regulatory services.
• Medical device companies: find contract manufacturers, sterilizers and relabelers near you.
• Recruiters and staffing firms: map device manufacturing sites by state.
• Consultants and market researchers: size a niche by product code, device class or specialty.

Input

Field	Default	What it does
countries	["US"]	2-letter ISO codes of the establishment address (US, CA, DE, CN...). Empty = all countries.
states	all	US states: TX, ca, Minnesota...
establishmentTypes	contract_manufacturer	Any of: manufacturer, contract_manufacturer, contract_sterilizer, repackager_relabeler, specification_developer, complaint_file, foreign_exporter, us_export_only_manufacturer, remanufacturer, single_use_reprocessor, foreign_private_label_distributor. Empty = all types.
productCodes	all	3-letter FDA product codes, e.g. FRO (wound dressings). Look them up in FDA's Product Classification database.
deviceClasses	all	1, 2, 3, U (unclassified), N (not classified), F (HDE).
medicalSpecialties	all	FDA review panels, e.g. Orthopedic, Dental, Cardiovascular.
companyName	empty	A word or phrase matched against the establishment name and the owner/operator company name.
onlyInitialImporters	false	Keep only establishments FDA flags as initial importers.
maxResults	100	Stop after this many establishments (up to 50,000).
maxProductsPerRow	25	Caps the products, deviceNames, proprietaryNames and premarketNumbers lists. productCodes and medicalSpecialties are always complete.
maxApiCalls	400	Safety cap on openFDA requests per run (each reads up to 1,000 listing records).
openFdaApiKey	empty	Optional, secret. Not needed. If you already have your own free openFDA key, add it to use openFDA's higher daily limit.

{
  "countries": ["US"],
  "states": ["MN", "MA", "CA"],
  "establishmentTypes": ["contract_manufacturer", "contract_sterilizer"],
  "deviceClasses": ["2", "3"],
  "maxResults": 1000
}

All filters are combined with AND. Values inside one filter are combined with OR.

What's in each row?

Area	Fields
Company	companyName (establishment name as registered), registrationNumber, feiNumber, registrationStatus, registrationExpiresYear, ownerOperatorName (owner/operator company), ownerOperatorNumber
Registered business address	street, city, state, zipCode, country, address (one line)
Establishment type	establishmentTypes, isManufacturer, isContractManufacturer, isContractSterilizer, isRepackagerRelabeler, isInitialImporter
Devices	productCodes, productCodeCount, deviceClasses, highestDeviceClass, medicalSpecialties, deviceNames, proprietaryNames, premarketNumbers (510(k)/PMA/De Novo), products (code, device name, class, specialty, regulation number, exempt flag, listed date), productsTruncated, listingRecords, firstListedDate, latestListedDate
Links and credit	fdaDatabaseUrl (FDA's own record search), sourceUrl (the openFDA API record), source, disclaimer, dataLastUpdated, retrievedAt

There are no personal names, phone numbers or email addresses in the output: the official correspondent, the US agent and the owner/operator contact address are never copied. Phone numbers and emails are also stripped from names and address lines. A run summary (filters, counts, openFDA requests) is saved as RUN_SUMMARY in the run's key-value store.

Output example

A real row from a local run of the default input on 2026-10-28. The proprietaryNames list is shortened here from 25 to 5 names; everything else is as saved.

{
  "companyName": "FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.",
  "registrationNumber": "1000118628",
  "feiNumber": "1000118628",
  "registrationStatus": "Active",
  "registrationExpiresYear": "2026",
  "establishmentTypes": [
    "Manufacture Medical Device for Another Party (Contract Manufacturer)",
    "Repack or Relabel Medical Device",
    "Manufacture Medical Device"
  ],
  "isManufacturer": true,
  "isContractManufacturer": true,
  "isContractSterilizer": false,
  "isRepackagerRelabeler": true,
  "isInitialImporter": true,
  "street": "2928 Metro Street, Suite 102",
  "city": "Denton",
  "state": "TX",
  "zipCode": "76207",
  "country": "US",
  "address": "2928 Metro Street, Suite 102, Denton, TX 76207, US",
  "ownerOperatorName": "Five Star Orthodontic Laboratory & Supply, Inc.",
  "ownerOperatorNumber": "10033551",
  "productCodes": [
    "LQZ",
    "LRK",
    "DZC"
  ],
  "productCodeCount": 3,
  "deviceClasses": [
    "1",
    "2"
  ],
  "highestDeviceClass": "Class II",
  "medicalSpecialties": [
    "Dental"
  ],
  "deviceNames": [
    "Device, Jaw Repositioning",
    "Device, Anti-Snoring",
    "Wire, Orthodontic"
  ],
  "proprietaryNames": [
    "mmRNA",
    "Vivos mRNA Appliance",
    "TAP III Anti-Snoring Device",
    "DreamTAP",
    "Elastic Mandibular Advancement (EMA)"
  ],
  "premarketNumbers": [],
  "products": [
    {
      "productCode": "LQZ",
      "deviceName": "Device, Jaw Repositioning",
      "deviceClass": "2",
      "deviceClassLabel": "Class II",
      "medicalSpecialty": "Dental",
      "regulationNumber": "872.5570",
      "exempt": null,
      "listedDate": "2021-08-19"
    },
    {
      "productCode": "LRK",
      "deviceName": "Device, Anti-Snoring",
      "deviceClass": "2",
      "deviceClassLabel": "Class II",
      "medicalSpecialty": "Dental",
      "regulationNumber": "872.5570",
      "exempt": null,
      "listedDate": "2021-08-19"
    },
    {
      "productCode": "DZC",
      "deviceName": "Wire, Orthodontic",
      "deviceClass": "1",
      "deviceClassLabel": "Class I",
      "medicalSpecialty": "Dental",
      "regulationNumber": "872.5410",
      "exempt": null,
      "listedDate": "2013-02-08"
    }
  ],
  "productsTruncated": false,
  "listingRecords": 5,
  "firstListedDate": "2013-02-05",
  "latestListedDate": "2021-08-19",
  "fdaDatabaseUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&RegistrationNumber=1000118628",
  "sourceUrl": "https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number%3A%221000118628%22&limit=100",
  "source": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov), openFDA device registration & listing dataset, public domain (CC0 1.0).",
  "disclaimer": "Not affiliated with, endorsed by or sponsored by the U.S. FDA. FDA registration and listing does not mean FDA approval or clearance of a firm or its devices. openFDA data is unvalidated; confirm details in FDA's own Establishment Registration & Device Listing database (fdaDatabaseUrl).",
  "dataLastUpdated": "2026-10-19",
  "retrievedAt": "2026-10-28T17:27:45Z"
}

Pricing

$3.00 per 1,000 leads. One lead event ($0.003) per saved establishment row. There's no start fee and no run fee. Runs that find nothing, and runs that fail because openFDA can't be reached, are free. If you set a maximum cost per run, the Actor stops cleanly when it reaches it.

Good to know

• Filters match listings. With a product code, class or specialty filter, a row's product lists contain only the listings that matched your filter, not everything the firm lists.
• Class III devices often have no specialty in openFDA, so a medicalSpecialties filter can miss them. Use deviceClasses or productCodes for Class III.
• Brand names in proprietaryNames are listed exactly as filed with FDA. A contract manufacturer may list its customers' brands. Trademarks belong to their owners.
• Registration isn't approval. Being listed doesn't mean FDA approved or cleared a firm or a device.
• Freshness: dataLastUpdated shows openFDA's last update of this dataset (2026-10-19 at the time of our tests). FDA's own database can be newer.
• Limits: openFDA allows 240 requests a minute and 1,000 a day per IP address without a key. A full US pull takes about 160 requests. If openFDA refuses requests, the run stops with a clear message and nothing is charged for missing rows.
• Use the data in line with your own legal and marketing obligations, such as CAN-SPAM and state privacy laws.

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FAQ

Is this an official FDA list? No. It's an independent tool built on openFDA's public data. It is not affiliated with or endorsed by FDA.

Does it include contact people, phones or emails? No, by design. You get the firm, its registered business address, its owner/operator company and links to FDA's own records.

Do I need an openFDA API key? No. The Actor works without one. You can optionally add your own key for a higher daily limit.

Is it legal to use this data? openFDA publishes this dataset as public domain (CC0 1.0). Use the results in line with your own legal and compliance obligations.