FDA AI-Enabled Medical Devices List Apify Actor

What does FDA AI-Enabled Medical Devices List Actor do?

This Actor scrapes the FDA's official List of AI-Enabled Medical Devices — the curated, regularly-updated table FDA publishes at fda.gov/medical-devices/.../artificial-intelligence-enabled-medical-devices identifying every medical device with AI/ML functionality authorized for U.S. marketing. It returns a normalized, per-device export covering the final decision date, submission number, submission detail link, device name, manufacturer, FDA medical specialty panel, and primary product code for every listed device — pulled directly from FDA's own table (currently ~1,525 rows). Run it on-demand or on a schedule to monitor for newly-authorized AI-enabled devices.

Why use this FDA AI-enabled medical devices scraper?

• Medtech competitive intelligence — track which companies and device categories are getting AI/ML authorizations, and how fast the list is growing.
• Regulatory affairs & consultants — build an internal reference of authorized AI-enabled devices by specialty panel or product code without manually browsing FDA's table.
• Digital health investors & analysts — screen the AI-enabled device landscape for market sizing, competitive mapping, and diligence on specific companies.
• AI governance & procurement teams — cross-reference a device against FDA's authoritative list before clinical adoption.

How to use FDA AI-Enabled Medical Devices List Actor

1. Click Try for free.
2. Leave the default Start URLs field as-is — it already points at FDA's AI-enabled devices list page (this is a single static page, not a multi-page directory).
3. Optionally set maxItems to cap how many rows are scraped (default 100; set higher, e.g. 2000, to capture the full current list).
4. Click Start and wait for the run to finish (typically well under a minute — the whole list loads in a single page fetch).
5. Download the results from the Dataset tab in JSON, CSV, Excel, or HTML.

Input

Field	Type	Description
startUrls	array (required)	FDA AI-enabled medical devices list page(s). Defaults to the official page — normally leave as-is.
maxItems	integer (default 100)	Maximum device rows to scrape.
delaySeconds	number (default 1.0)	Polite delay before each page fetch. Raise to 30 if you add extra start URLs, per FDA's robots.txt Crawl-Delay: 30 for general crawlers.
concurrency	integer (default 1)	How many start URLs to fetch at once. Defaults to sequential to respect FDA's crawl-delay guidance; irrelevant for the normal single-URL case.

Output

{
  "finalDecisionDate": "03/30/2026",
  "submissionNumber": "K254207",
  "submissionDetailUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254207",
  "deviceName": "AiORTA - Plan v2.0",
  "company": "ViTAA Medical Solutions, Inc.",
  "panel": "Radiology",
  "primaryProductCode": "QIH",
  "sourceRowOrder": 1,
  "sourceDownloadUrl": "https://www.fda.gov/media/178541/download?attachment",
  "scrapedAt": "2026-08-05T08:20:07.643994+00:00"
}

You can download the dataset in various formats such as JSON, HTML, CSV, or Excel.

Data table

Field	Description
finalDecisionDate	Date of FDA final decision, as published
submissionNumber	FDA premarket submission number (e.g. K254207)
submissionDetailUrl	Link to the submission's accessdata.fda.gov detail page (reference only — not crawled)
deviceName	Device/product name as listed
company	Manufacturer/submitter company name
panel	FDA medical specialty panel (lead), e.g. Radiology, Cardiovascular
primaryProductCode	FDA primary product code
sourceRowOrder	1-indexed row position in FDA's source table (reverse-chronological)
sourceDownloadUrl	FDA's official CSV/Excel download URL for the full list
scrapedAt	ISO-8601 UTC scrape timestamp

Pricing

$4.99 per 1,000 results. Example costs: 100 results ≈ $0.50, 500 results ≈ $2.50, 1,000 results ≈ $4.99, 5,000 results ≈ $24.95. This is a single-request, no-detail-page-fetch design, so pricing sits at the low end of comparable directory actors.

Tips or advanced options

• Set maxItems above FDA's current row count (currently ~1,525) to capture the entire list in one run.
• Run on a schedule (e.g. weekly) to catch newly-authorized devices as FDA updates the list — sourceRowOrder and finalDecisionDate make new additions easy to diff against a prior run.
• submissionDetailUrl links to FDA's public 510(k)/De Novo detail page for that submission if you need to look up additional filing information manually.

FAQ, disclaimers, and support

This Actor scrapes only FDA's publicly-published AI-enabled device list — no login is required and no personal/private data is collected. Data accuracy depends on FDA's published records at scrape time; always confirm against the official FDA source for regulatory-critical decisions. This Actor is not affiliated with or endorsed by the FDA. Found a bug or need a custom field/filter? Open an issue in the Actor's Issues tab.