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.

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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.

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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"
}

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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.

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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.

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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.

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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.

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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.

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