# FDA 510(k) Medical Device Clearances & MedTech B2B Lead API (`mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-scraper`) Actor

Extract official US FDA 510(k) medical device clearances (openFDA) into clean JSON/CSV. Get MedTech Company Names, Direct Contact Person Names, HQ Street Addresses, Cleared Device Trade Names, Specialties & Decision Dates. Built for MedTech B2B sales, stock traders, n8n & MCP AI.

- **URL**: https://apify.com/mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-scraper.md
- **Developed by:** [Mehdad Sharifi](https://apify.com/mehdad-datalabs) (community)
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $5.00 / 1,000 extracted fda 510(k) clearances

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

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

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
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.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## 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.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## FDA 510(k) Medical Device Clearances, MedTech Catalyst & B2B Lead Scraper API

Extract official US Food and Drug Administration (openFDA 510(k)) Premarket Medical Device Notifications and Clearances directly into clean JSON, CSV, or Excel datasets. Capture MedTech Applicant Company Name, Direct Contact Person Name (contactPersonName), HQ Street Address, City, State, ZIP, Cleared Device Trade Name, Medical Specialty, Device Class, and FDA Decision Date.

Built for MedTech B2B sales agencies, contract manufacturers (CMOs), medical device distributors, healthcare stock traders, n8n and Make automation workflows, and AI agents (Claude MCP and Cursor)—with zero proxy fees required.

***

### Why Choose This FDA 510(k) Medical Device Clearances API?

| Feature | How Buyers Profit From This Data |
| :--- | :--- |
| Direct MedTech Decision-Maker Contacts | Every 510(k) filing includes the Applicant Company Name, the Named Contact Person (contactPersonName), and their verified Street Address, City, State, and ZIP Code—giving B2B vendors direct access to MedTech companies launching new hardware and software. |
| MedTech Stock Catalyst Tracking | Monitor new FDA 510(k) device clearances (Substantially Equivalent) for public MedTech leaders (ISRG, ABT, MDT, SYK, BSX, GEHC, DXCM) and AI-enabled radiology and surgical startups. |
| Specialty & Device Class Filtering | Captures the FDA Advisory Committee Medical Specialty (Orthopedic, Cardiovascular, Neurology, Radiology, General and Plastic Surgery), 3-letter Product Code, and Device Class (Class 1, 2, or 3). |
| Zero Proxy or API Key Costs | Connects directly to official US Government api.fda.gov/device/510k endpoints—blazing fast and zero residential proxy costs. |
| AI Agent & MCP Server Ready | Plug directly into Claude Desktop, Cursor, Clay, n8n, Make, or Zapier for automated MedTech lead generation and regulatory intelligence. |

***

### What Data Does This Actor Extract? (Sample JSON Output)

Every FDA 510(k) medical device clearance is flattened into a clean, structured JSON record:

```
{
  "kNumber": "K251842",
  "applicantCompany": "MEDTRONIC NAVIGATION, INC.",
  "contactPersonName": "SARAH JENKINS",
  "deviceName": "STEALTHSTATION AI SURGICAL NAVIGATION SYSTEM",
  "genericCategoryName": "Stereotaxic Instrument",
  "medicalSpecialty": "Neurology",
  "deviceClass": "Class 2",
  "productCode": "HAW",
  "regulationNumber": "882.4560",
  "decisionDate": "2026-09-18",
  "dateReceived": "2026-06-12",
  "decisionCode": "SESE",
  "decisionDescription": "Substantially Equivalent",
  "clearanceType": "Traditional",
  "statementOrSummary": "Summary",
  "streetAddress": "826 COAL CREEK CIRCLE",
  "city": "LOUISVILLE",
  "state": "CO",
  "zipCode": "80027",
  "countryCode": "US",
  "matchedQuery": "Robotic",
  "fda510kUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251842"
}
```

***

### How to Use FDA 510(k) Medical Device Clearances Scraper

1. Enter MedTech Companies, Device Keywords, or Specialties: Add one or more medical device keywords, clinical specialties, or manufacturer names (e.g., Robotic, Ultrasound, Orthopedic, AI, Medtronic, Abbott, Stryker).
2. Set Max 510(k) Clearances to Extract: Choose how many cleared device and B2B lead records to retrieve per run (default: 30, up to 500+).
3. Run & Export: Click Start and download your dataset in JSON, CSV, Excel, or XML, or send leads directly into Clay, HubSpot, Salesforce, or Google Sheets via the Apify REST API.

***

### FDA 510(k) B2B Lead & Regulatory Fields Reference

| Field Name | Description | Commercial & B2B Sales Value |
| :--- | :--- | :--- |
| applicantCompany | MedTech Manufacturer / Sponsor Name | Identifies the exact company that owns and commercializes the newly cleared medical device. |
| contactPersonName | Official 510(k) Correspondent / Executive | Provides the exact full name of the VP of Regulatory Affairs, Quality Director, or MedTech Founder for personalized cold outreach. |
| streetAddress, city, state, zipCode | Verified Manufacturer HQ Address | Complete physical address for B2B territory routing, direct mail, and CRM account enrichment. |
| decisionDate & dateReceived | FDA Clearance Date & Submission Date | Calculates exact FDA review turnaround times and spots devices cleared this week for immediate commercial launch outreach. |
| clearanceType | Traditional, Special, or Abbreviated 510(k) | Distinguishes brand-new device clearances (Traditional) from iterative device modifications (Special). |
| fda510kUrl | Direct Official FDA CDRH Summary Link | One-click access to the official FDA 510(k) summary PDF and predicate device comparison. |

***

### Transparent Pay-Per-Event Pricing

You only pay for the exact FDA 510(k) clearance records extracted:

- Actor Startup (apify-actor-start): USD 0.01 per run.
- Extracted 510(k) Clearance (fda-510k-extracted): USD 0.005 per parsed FDA 510(k) clearance and B2B lead record (USD 5.00 per 1,000 records).
- Free Tier Friendly: With Apify's free USD 5.00 monthly credit, you can extract nearly 1,000 FDA 510(k) medical device clearances every month for free.

***

### Top Use Cases

- MedTech B2B Outbound Sales & Contract Manufacturing (CMO): The moment a MedTech company receives FDA 510(k) clearance, they transition from R\&D to commercial manufacturing—actively hiring precision machining vendors, medical packaging suppliers, sterilization facilities, and medical sales reps.
- Healthcare & MedTech Stock Catalyst Tracking: Monitor FDA 510(k) clearances across public medical device giants (ISRG, ABT, MDT, SYK, BSX, ZBH) before commercial product launches are priced in.
- Predicate Device & Regulatory Affairs Research: Quickly search historical 510(k) clearances by keyword, specialty, or product code to find predicate devices for new FDA submissions.
- AI Healthcare Research Agents (MCP): Give Claude Desktop, Cursor, or LangChain live access to verified FDA 510(k) clearance data via Apify's Model Context Protocol (MCP) server.

***

### Frequently Asked Questions (FAQ)

#### What is an FDA 510(k) Premarket Notification Clearance?

A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a new Class I, II, or III medical device to be marketed is safe, effective, and "Substantially Equivalent" (SESE) to a legally marketed predicate device. Once cleared by the FDA, the manufacturer can legally commercialize and sell the device in the United States.

#### Why is FDA 510(k) clearance the #1 B2B sales trigger in MedTech?

Before 510(k) clearance, medical device companies cannot legally sell their product in the US. The week a company receives its K-number clearance is the exact moment they unlock commercial budgets for contract manufacturing, cleanroom assembly, logistics, hospital sales distribution, and healthcare marketing—and the 510(k) record gives you the exact Contact Person Name and HQ address.

#### How can I connect this FDA 510(k) API to Clay, n8n, Python, or Google Sheets?

You can trigger this Actor via the Apify REST API, the apify-client Python or Node.js SDK, or the native Apify integration inside Clay, n8n, Make, and Zapier to automatically enrich contacts and push leads to your CRM.

***

### Explore Our Complete 20-API Financial, Biotech & B2B Intelligence Suite

- [SEC Form 4 Insider Trading Scraper & XML Parser API](https://apify.com/mehdad-datalabs/sec-form-4-insider-trading-scraper-xml-parser-api)
- [SEC Form 13F Institutional Holdings & Hedge Fund Whale Scraper](https://apify.com/mehdad-datalabs/sec-13f-institutional-holdings-hedge-fund-whale-scraper)
- [SEC Form N-PORT Mutual Fund & ETF Portfolio Holdings API](https://apify.com/mehdad-datalabs/sec-nport-etf-mutual-fund-holdings-xml-scraper)
- [SEC 10-K & 10-Q XBRL Financial Statements & Earnings API](https://apify.com/mehdad-datalabs/sec-10k-10q-xbrl-financial-statements-earnings-api)
- [SEC Form 8-K Corporate Events, M\&A & Executive Change Scraper](https://apify.com/mehdad-datalabs/sec-8k-corporate-events-ma-executive-change-scraper)
- [SEC Schedule 13D & 13G Activist Investor & 5%+ Ownership API](https://apify.com/mehdad-datalabs/sec-schedule-13d-13g-activist-investor-ownership-api)
- [SEC Form S-1 IPO Pipeline & Form 144 Insider Sale Notice API](https://apify.com/mehdad-datalabs/sec-ipo-s1-form144-insider-sale-scraper)
- [SEC Form D Startup Funding, VC Raise & Founder B2B Lead API](https://apify.com/mehdad-datalabs/sec-form-d-startup-funding-vc-b2b-lead-scraper)
- [SEC DEF 14A Executive Compensation & Proxy Statement API](https://apify.com/mehdad-datalabs/sec-def14a-ceo-executive-compensation-proxy-scraper)
- [SEC Form 20-F & 6-K Global ADR & Foreign Stock Filings API](https://apify.com/mehdad-datalabs/sec-20f-6k-foreign-adr-international-stock-scraper)
- [CFPB Fintech & Bank Consumer Complaint Intelligence API](https://apify.com/mehdad-datalabs/cfpb-fintech-bank-consumer-complaint-b2b-scraper)
- [FDIC US Bank Directory, Deposits, Assets & B2B Lead API](https://apify.com/mehdad-datalabs/fdic-us-bank-directory-deposits-assets-b2b-scraper)
- [FDA Drug, Device & Food Recall Enforcement & Legal Lead API](https://apify.com/mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper)
- [US Pharmacy, Clinical Lab & Medical Supply B2B Lead API](https://apify.com/mehdad-datalabs/us-pharmacy-medical-lab-dme-b2b-lead-scraper)
- [US Public Company B2B Directory, SIC & HQ Phone API](https://apify.com/mehdad-datalabs/us-public-company-b2b-profile-sic-hq-phone-scraper)
- [US Federal Government Contract Awards & DoD B2B Lead Scraper](https://apify.com/mehdad-datalabs/us-federal-government-contract-awards-dod-b2b-scraper)
- [FDA Drug Approvals, NDA/BLA Biotech Catalyst & Pharma API](https://apify.com/mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper)
- [ClinicalTrials.gov Phase 1-3 Biotech Catalyst & B2B Lead API](https://apify.com/mehdad-datalabs/clinical-trials-biotech-catalyst-cro-b2b-lead-scraper)
- [US Doctor, Dentist & Medical Clinic B2B Lead Scraper API](https://apify.com/mehdad-datalabs/us-doctor-dentist-clinic-healthcare-b2b-lead-scraper)

# Actor input Schema

## `searchQueries` (type: `array`):

Enter medical device keywords, clinical specialties, or MedTech company names to extract FDA 510(k) clearances.

## `maxResults` (type: `integer`):

Maximum number of FDA 510(k) medical device clearance & B2B lead records to extract.

## Actor input object example

```json
{
  "searchQueries": [
    "Robotic",
    "Ultrasound",
    "Medtronic",
    "Abbott"
  ],
  "maxResults": 30
}
```

# Actor output Schema

## `dataset` (type: `string`):

Clean table of FDA 510(k) cleared medical devices, MedTech company names, contact persons, addresses, and decision dates

# 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 = {};

// Run the Actor and wait for it to finish
const run = await client.actor("mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-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 = {}

# Run the Actor and wait for it to finish
run = client.actor("mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-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 '{}' |
apify call mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-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/4wcNQEjDbMRwf9OXO/builds/tOJa0LSDmWBhpuMAa/openapi.json