FDA Device Establishment Lookup

One record per FDA-registered medical device establishment that matches your search: firm name, registration or FEI number, product code, device class, brand name, 510(k)/De Novo/PMA number, country, state or the operations the facility performs (manufacturer, contract manufacturer, sterilizer…). Each record joins the facility's registration (status, address, owner/operator, US agent) to the device listings that matched, with each listing's product codes, device names, classes, regulation numbers and the premarket numbers it cites, linked to FDA's own databases. Built for medtech QA, supplier-qualification, regulatory and sales teams who need "every contract sterilizer in California" or "who manufactures under product code DXY", not the raw listing download.

Pricing: pay per event. establishment-record: one event per establishment returned (not per listing). A search with no matches costs you nothing.

A search is required: at least one of firm names, registration / FEI numbers, product codes, proprietary names, premarket numbers, states, countries or a listing-date window. Operations and device classes only narrow another filter. Different fields combine with AND; entries within one field combine with OR.

Product filters apply to one device. "Product code JJE, class III" means one listed device that is both. openFDA's own search matches those conditions across different devices of a listing: in a live check, all 3 hits for that query were near-misses. This Actor re-checks every hit and never charges for one.

Input

{"states": ["CA"], "establishment_types": ["contract_sterilizer"]}

Who makes devices under a product code, class III only:

{"product_codes": ["DXY"], "device_classes": ["3"]}

Which establishments cite a clearance or approval:

{"premarket_numbers": ["K103680", "DEN220039", "P990040"]}

Firm names are whole-word phrases matched against both the facility name and its owner/operator (steris finds STERIS-owned Isomedix sites).

Scheduled watches: turn on Changes only. The first run records a baseline of the search and charges nothing. Later runs return only establishments that are new, changed (device listings added or removed, registration status, operations, registration year) or gone, each with change_type and change_details. A change is reported exactly once. openFDA refreshes this data monthly, and a run on unchanged data stops after one request. A watch can cover up to 15,000 listings.

Example output (one dataset item per establishment)

{
 "establishment_key": "reg:3007904765",
 "registration_number": "3007904765",
 "fei_number": "3007904765",
 "name": "ABIOMED EUROPE GMBH",
 "status": "Active",
 "registration_expiry_year": "2026",
 "city": "Aachen North Rhine-Westphalia",
 "country": "DE",
 "owner_operator_name": "Abiomed Europe GmbH",
 "us_agent_business_name": "Abiomed, Inc.",
 "establishment_types": [
  "Manufacture Medical Device"
 ],
 "product_codes": [
  "PYX",
  "OZD"
 ],
 "device_classes": [
  "3"
 ],
 "pma_numbers": [
  "P170011",
  "P140003"
 ],
 "listing_count": 2,
 "listings": [
  {
   "product_codes": [
    "PYX"
   ],
   "device_names": [
    "Temporary Non-Roller Type Right Heart Support Blood Pump"
   ],
   "device_classes": [
    "3"
   ],
   "regulation_numbers": [
    "870.4360"
   ],
   "proprietary_names": [
    "Impella RP",
    "Impella RP Flex with SmartAssist",
    "Impella RP with SmartAssist"
   ],
   "pma_number": "P170011",
   "premarket_type": "PMA",
   "premarket_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170011",
   "listed_dates": [
    "2017-11-09"
   ]
  }
 ],
 "fda_registration_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&RegistrationNumber=3007904765",
 "change_type": null,
 "data_last_updated": "2026-09-14"
}

(Abridged: every field in the table below is always present, empty or null when the source has no value.)

Output fields

One dataset item per establishment; every field is always present (empty or null when the source has no value). Defined in .actor/dataset_schema.json.

Field	Type	Description
establishment_key	string	Stable id: reg:
registration_number	string	FDA establishment registration number (null while awaiting assignment)
fei_number	string	FDA Establishment Identifier (FEI)
name	string	Establishment (facility) name
status	string	Registration status: Active, or Active awaiting assignment of registration number
status_code	string	Registration status code (1 or 5)
registration_expiry_year	string	Year the registration expires (on 31 December)
initial_importer	boolean	Whether the facility is an initial importer
address_line_1	string	Facility address line 1
address_line_2	string	Facility address line 2
city	string	Facility city
state	string	Facility US state code
postal_code	string	Facility ZIP or postal code
country	string	Facility ISO country code
owner_operator_name	string	Owner/operator firm name
owner_operator_number	string	Owner/operator number assigned by CDRH
owner_operator_country	string	Owner/operator contact country
us_agent_business_name	string	US agent business name (foreign establishments)
us_agent_country	string	US agent country
establishment_types	array	Operations performed, across the returned listings
product_codes	array	Product codes across the returned listings
device_classes	array	Device classes across the returned listings (1, 2, 3, U, N, F = HDE)
k_numbers	array	510(k) numbers cited by the returned listings
de_novo_numbers	array	De Novo numbers cited by the returned listings
pma_numbers	array	PMA numbers cited by the returned listings
listing_count	integer	Number of returned (matching) device listings
listings_truncated	boolean	True when more than 300 listings matched and only the first 300 are carried
listings	array	The matching device listings: product codes, device names, classes, regulation numbers, specialties, proprietary names, operations, 510(k)/De Novo/PMA number with type and FDA database link, exempt flag, listing dates
fda_registration_url	string	FDA Establishment Registration & Device Listing page for this registration number
change_type	string	Changes-only mode: new_establishment, updated or removed; null in lookup mode
change_details	object	Changes-only mode: added_listings, removed_listings and changed_fields (old/new); null in lookup mode
data_last_updated	string	openFDA dataset refresh date (openFDA refreshes this data monthly)

Coverage and limits

• Premarket links are partial, as in FDA's data. 38% of listings cite a 510(k) or De Novo number and 0.7% a PMA number; exempt and class I devices usually cite none. Links go only to FDA database pages verified to resolve (510(k), De Novo, PMA).
• Counts are openFDA's. FDA's live Establishment Registration & Device Listing site can show more listings for a facility than openFDA carries. Each record links the FDA page for the registration.
• Freshness: openFDA refreshes this dataset monthly. On 2026-09-23 the data was dated 2026-09-14, with listings created through 2026-09-13. openFDA notes listing dates "may be unreliable".
• Registrations awaiting a number (status 5) have no registration or FEI number and are keyed by owner/operator number and name.
• A lookup reads at most 20,000 listings per run; the status message says when a search has more.

Runs stop cleanly at your max-charge limit: nothing is pushed past what you agreed to pay for.

Source and terms

Source: the openFDA device registration & listing API (api.fda.gov/device/registrationlisting.json). The data is public domain (CC0 1.0). openFDA's disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated." This Actor is not affiliated with or endorsed by the FDA. An optional free openFDA API key lifts the unkeyed limit of 1,000 requests per day per IP (Apify IPs are shared).

Related: the FDA 510(k) / PMA Clearance Monitor for new clearance decisions, the FDA Drugs@FDA Application Lookup for drug applications, and the FDA Recall Monitor for enforcement recalls.