🛡️ FDA Device Establishment Listings

One establishment_record per FDA device establishment registration from the official openFDA endpoint — keyless, logged-out.

Difference: One record per device establishment registration, preserving the registration↔listing relation: establishment name, registration + FEI numbers, establishment types, status, organisation address (city/state/country/zip), and the listed product codes with device names and classes. US-agent and owner-operator / official-correspondent personal-contact fields are stripped at ingest.

Output is one fda_device_establishment row per result; billing is pay-per-event, the value event being one fda device establishment listings (a $0.02 start fee per run, then $0.02 per fda device establishment listings). Source: api.fda.gov.

No login, no API key and no CAPTCHA solving are involved: the source is read logged-out with an identified contact User-Agent.

📊 Sample Output

Real rows from run oE9cTwEOs7g3VMAwu on build 0.1.5 (2026-09-18), the same input as the Quick start below — every value is as the source published it (emails masked, long text shortened):

registration_number	fei_number	establishment_name	city	product_codes	medical_specialties
3016851379	3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg	["HRS", "HWC", "PLF"]	["Orthopedic"]
3017894900	3017894900	Philips Ultrasound LLC	Cambridge	["ITX", "IYN", "IYO"]	["Radiology"]
1424263	3003015552	Isomedix Operations, Inc.	Libertyville	["HSB"]	["Orthopedic"]
3013413393	3013413393	Avalign Additive / Slice Manufacturing Studios	Akron	["ODP", "OVE"]	["Orthopedic"]
3007942528	3007942528	WELLPOWER SPORTING GOODS CO., LTD.	Dong Guan Guangdong	["FXX"]	["General, Plastic Surgery"]
9614705	3009523116	KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT	MIYOSHI Aichi	["EIH"]	["Dental"]
3021482081	3021482081	EMP TECH PRO INC	Miami	["JJQ"]	["Clinical Chemistry"]
1424263	3003015552	Isomedix Operations, Inc.	Libertyville	["ODP"]	["Orthopedic"]

The run finished with the status message: NORMAL: 50 unique rows (0 duplicates collapsed). billable=50

✅ What you get

Each row is flat JSON with these fields (from the dataset schema and the sample run; a field the source does not publish for a given row is null):

• record_type (string) — e.g. fda_device_establishment
• registration_number (string/null) — e.g. 3016851379
• fei_number (string/null) — e.g. 3016851379
• establishment_name (string/null) — e.g. Arthrex Distribution Hub EMEA B.V.
• establishment_types (string/null) — e.g. ["Export Device to the United States But Perform No Other Operation on Device"]
• status_code (string/null) — e.g. 1
• registration_expiry_year (string/null) — e.g. 2026
• initial_importer_flag (string/null) — e.g. N
• city (string/null) — e.g. Venlo Limburg
• state_code (string/null) — e.g. MA
• iso_country_code (string/null) — e.g. NL
• zip_code (string/null) — e.g. 5928 PE
• proprietary_names (string/null) — e.g. ["Biosync", "Biosync Bone wedge", "Metallic Bone Fixation"]
• k_number (string/null) — e.g. "K151256"
• pma_number (string/null) — null in every sample row
• product_codes (string/null) — e.g. ["HRS", "HWC", "PLF"]
• device_names (string/null) — e.g. ["Bone Wedge", "Plate, Fixation, Bone", "Screw, Fixation, Bone"]
• device_classes (string/null) — e.g. ["2"]
• medical_specialties (string/null) — e.g. ["Orthopedic"]
• product_count (string/null) — e.g. 3
• source (string/null) — e.g. fda-device-establishment-listings
• release_date (string/null) — null in every sample row
• source_url (string/null) — e.g. https://api.fda.gov/device/registrationlisting.json
• observed_at (string/null) — e.g. 2026-09-18T20:58:13Z
• license (string/integer/null) — e.g. openFDA — U.S. Food & Drug Administration public data
• attribution (string/integer/null) — e.g. Source: openFDA Device Registration & Listing (api.fda.gov); not for clinical us
• terminal (string/integer/null) — null in every sample row
• reported_total (string/integer/null) — null in every sample row
• raw_seen (string/integer/null) — null in every sample row
• duplicates (string/integer/null) — null in every sample row
• unique_found (string/integer/null) — null in every sample row
• delivered (string/integer/null) — null in every sample row
• scope (string/integer/null) — null in every sample row
• note (string/integer/null) — null in every sample row

What you get

One establishment_record per record, deduplicated on its natural key. A run_receipt row carries the source URL, scope, license, attribution, and totals.

⚙️ Sample inputs

1. Quick start — the Store example (this is what the sample above came from)

{
  "maxRecords": 50
}

The sample run charged exactly: 1 × $0.02 apify-actor-start + 50 × $0.02 establishment_record = $1.02 on the Free tier — every delivered row was billed.

2. A smaller, narrowed run

{
  "maxRecords": 5
}

Caps the run at 5 rows — about $0.12 on the Free tier ($0.02 start + 5 × $0.02).

3. A full-size run

{
  "maxRecords": 5000
}

Up to 5000 rows (the schema default for maxRecords) — about $100.02 on the Free tier ($0.02 start + 5000 × $0.02) if the source has that many.

🧾 JSON sample record

One real record from run oE9cTwEOs7g3VMAwu, exactly as it lands in the dataset (emails masked, long text shortened):

{
  "record_type": "fda_device_establishment",
  "registration_number": "3016851379",
  "fei_number": "3016851379",
  "establishment_name": "Arthrex Distribution Hub EMEA B.V.",
  "establishment_types": "[\"Export Device to the United States But Perform No Other Operation on Device\"]",
  "status_code": "1",
  "registration_expiry_year": "2026",
  "initial_importer_flag": "N",
  "city": "Venlo Limburg",
  "state_code": null,
  "iso_country_code": "NL",
  "zip_code": "5928 PE",
  "proprietary_names": "[\"Biosync\", \"Biosync Bone wedge\", \"Metallic Bone Fixation\"]",
  "k_number": "\"K151256\"",
  "pma_number": null,
  "product_codes": "[\"HRS\", \"HWC\", \"PLF\"]",
  "device_names": "[\"Bone Wedge\", \"Plate, Fixation, Bone\", \"Screw, Fixation, Bone\"]",
  "device_classes": "[\"2\"]",
  "medical_specialties": "[\"Orthopedic\"]",
  "product_count": "3",
  "source": "fda-device-establishment-listings",
  "release_date": null,
  "source_url": "https://api.fda.gov/device/registrationlisting.json",
  "observed_at": "2026-09-18T20:58:13Z",
  "license": "openFDA — U.S. Food & Drug Administration public data",
  "attribution": "Source: openFDA Device Registration & Listing (api.fda.gov); not for clinical use"
}

🔧 How it works

Transport. Plain HTTPS from the Apify platform, no proxy. robots.txt is read first and a disallowed path is never fetched. Every request carries an identified contact User-Agent.

Charging. Each fda device establishment listings is charged at the moment it is pushed (establishment_record); a row that fails to charge is not delivered, so the dataset count always equals the charged count.

How it behaves

The openFDA device registration & listing endpoint is paged at the 1,000-record page law and each registration normalized; personal-contact fields are never read (whitelist). Bounded.

Source

https://api.fda.gov/device/registrationlisting.json

Attribution

Source: openFDA Device Registration & Listing (api.fda.gov), U.S. FDA public data. Not for clinical use.

What is not done. No login, no cookie or CAPTCHA bypass, no private or personal-account data, no browser automation.

💰 Pricing example

Event	Free	Bronze	Silver	Gold
Actor Start (apify-actor-start)	$0.02	$0.02	$0.02	$0.02
FDA Device Establishment Listings (establishment_record)	$0.02	$0.02	$0.02	$0.01

Worked at the live Free-tier price:

• 8 fda device establishment listingss: $0.02 start + 8 × $0.02 = $0.18
• 25 fda device establishment listingss: $0.02 start + 25 × $0.02 = $0.52
• 5000 fda device establishment listingss: $0.02 start + 5000 × $0.02 = $100.02

A run that delivers zero rows charges the $0.02 start fee only. A BLOCKED run (source refused) fails loud and charges no value event. The start fee is charged once per GB of run memory; the default run memory is 4096 MB.

Yield on the sample run: NORMAL: 50 unique rows (0 duplicates collapsed). billable=50. maxRecords is a hard ceiling on what is delivered and billed, never a target.

⚖️ Legal & ToS

This actor reads public, logged-out pages and feeds published by api.fda.gov. It collects only what the source publishes to any visitor, keeps to the source's robots rules (checked on every run), identifies itself with a contact User-Agent, and does not access accounts, private data or anything behind authentication. Use the output in line with the source's terms and your local law; the intended use is B2B research and monitoring.

❓ FAQ

Q: Do I need an API key or a login?
A: No. The source (api.fda.gov) is read logged-out; the input schema has no key field and the actor carries no secrets.

Q: Why did my run return 0 rows?
A: Read the run's status message. GENUINE_EMPTY means the source was read and had nothing in scope for your input; BLOCKED means the source refused and the run failed without billing a value event — retry later or narrow the input. A zero-row run bills the start fee only.

Q: How many rows can one run return?
A: Up to maxRecords (default 5000). Raise the cap for a bigger run; you pay per delivered row.

Q: How fresh is the data?
A: Every run reads the source live at run time; nothing is cached between runs. Put it on a schedule for a continuous feed.

Q: What formats can I export?
A: The dataset downloads as JSON, CSV, Excel, XML or RSS from the run's Dataset tab or the Apify API, and any run can push to a webhook or integration.

Q: How is this different from the other product safety and approvals watches actors?
A: Same output shape and billing model; this one covers api.fda.gov. The siblings under Related Actors cover the other sources or slices — run several on one schedule for a combined feed.

Q: Are there rate limits?
A: The actor paces itself against the source and honours its robots rules; there is no per-buyer limit beyond your Apify plan's concurrency.

🆘 Troubleshooting

• Run FAILED with BLOCKED → the source refused the request or changed its page shape → nothing was billed beyond the start fee; retry after a while, and if it persists open an Issue with the run id.
• Status says CAPPED → your cap (maxRecords) was reached → raise it for a bigger run.
• Input validation error on start → a field is outside the schema's allowed values → start from the Quick start block and change one field at a time.
• Run TIMED-OUT → a very wide request on a slow day → raise the run timeout in Run options or narrow the input; what was delivered before the timeout is still in the dataset.

🔗 Related Actors

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• FDA 510(k) Device Clearances — Clean, structured records of medical-device 510(k) clearances, sourced live from the
• FDA Drug Approvals (Drugs@FDA) — Clean, structured records of FDA drug approvals, sourced live from the official openFDA
• FDA NDC Product Directory — same family, different source
• Japan PMDA New Drug Approval Watch — Japanese new-drug approvals as PMDA records them: approval date, brand name, marketing-authorisation holder with its corporate number, active ingredi…
• 🏢 About NexGenData — NexGen Watch is NexGenData's fleet of 256 public monitoring and lookup actors built on official sources, pay-per-result. Browse the catalog at apify.com/nexgenwatch.

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