# FDA Registered Medical Device Establishments Scraper (`scrapers_lat/openfda-device-establishments-scraper`) Actor

Directory of FDA-registered medical device establishments: manufacturers, importers, sterilizers and contract makers with owner/operator, US agent contact (name, phone, email), full address, FEI/registration number and listed products. Export to JSON, CSV or Excel.

- **URL**: https://apify.com/scrapers\_lat/openfda-device-establishments-scraper.md
- **Developed by:** [Scrapers Lat](https://apify.com/scrapers_lat) (community)
- **Categories:** Automation, Developer tools
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $15.00 / 1,000 results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## 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

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

### Example output

```json
{
  "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.

# Actor input Schema

## `maxRecords` (type: `integer`):

Maximum number of establishments to collect. Optional. The source paginates up to 26000 records per query, so for very large pulls narrow by country, state or product code.

## `searchQuery` (type: `string`):

A simple keyword (matched to the establishment name), or a raw openFDA-style expression containing a field, for example registration.owner\_operator.firm\_name:"Medtronic" or products.openfda.device\_name:catheter. Leave empty to pull the most recent registrations.

## `companyName` (type: `string`):

Filter by the registered establishment name or its owner/operator firm name (matches either), for example Boston Scientific.

## `productCode` (type: `string`):

Three-letter FDA product code of a device the establishment lists, for example LLZ (infusion pump) or DXN. Comma-separate for multiple.

## `deviceName` (type: `string`):

Keyword matched against the FDA device name of the establishment's listed products, for example catheter, stent, ventilator.

## `establishmentType` (type: `string`):

Limit to establishments performing a given operation.

## `deviceClass` (type: `string`):

Limit to establishments listing at least one device of this FDA risk class.

## `country` (type: `string`):

Two-letter ISO country code of the establishment, for example US, DE, CN, JP.

## `state` (type: `string`):

Two-letter US state code of the establishment, for example CA, MA, MN. Applies to US establishments.

## `initialImporterOnly` (type: `boolean`):

Only return establishments flagged as initial importers of devices into the United States.

## `proxyConfiguration` (type: `object`):

Optional. The source is a keyless public API and normally needs no proxy.

## Actor input object example

```json
{
  "maxRecords": 10,
  "establishmentType": "",
  "deviceClass": "",
  "initialImporterOnly": false
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "maxRecords": 10,
    "searchQuery": ""
};

// Run the Actor and wait for it to finish
const run = await client.actor("scrapers_lat/openfda-device-establishments-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "maxRecords": 10,
    "searchQuery": "",
}

# Run the Actor and wait for it to finish
run = client.actor("scrapers_lat/openfda-device-establishments-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "maxRecords": 10,
  "searchQuery": ""
}' |
apify call scrapers_lat/openfda-device-establishments-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,scrapers_lat/openfda-device-establishments-scraper"
        }
    }
}

```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/gfOFa1nRcxA04Hb7P/builds/NAefjxdWMHp7UH0Ah/openapi.json