# openFDA 510(k) Medical Devices, Recalls & Drug NDC Scraper MCP (`acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp`) Actor

Extract flattened US FDA 510(k) medical device clearances, applicant companies, device recalls, and Drug NDC directory records for MedTech due diligence, legal compliance, and AI Agents.

- **URL**: https://apify.com/acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp.md
- **Developed by:** [Thinh Le](https://apify.com/acer_quant_ai) (community)
- **Stats:** 2 total users, 1 monthly users, 0.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $5.00 / 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.

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

## openFDA 510(k) Medical Devices, Recalls & Drug NDC Scraper MCP

Extract flattened, structured records from the official **US FDA (openFDA) databases**: **510(k) Medical Device Clearances**, **Drug NDC Directory**, and **Medical Device Enforcement Recalls**.

### High-ROI MedTech, Legal & Pharma Use Cases

- **MedTech Investor & M\&A Due Diligence**: Track newly cleared 510(k) medical devices, applicant companies, product codes, and regulatory decision dates.
- **Product Liability & Legal Compliance**: Monitor FDA device recalls (device_recall) and enforcement actions across manufacturers in real time.
- **Pharmaceutical Supply Chain & AI Agents**: Query structured Drug NDC codes, brand/generic names, and labelers via MCP.

### Transparent Pay-Per-Event (PPE) Pricing

Up to **70% more affordable** than legacy FDA scrapers while running at pure-HTTP speed:

| Volume | Event Price | Estimated Total Cost | Speed (128MB RAM) |
| :--- | :--- | :--- | :--- |
| **200 FDA Records** | $0.005 / record | **$1.00** | ~1 second |
| **1,000 FDA Records** | $0.005 / record | **$5.00** | ~4 seconds |

### Sample JSON Output

```json
{
  "datasetType": "device_510k",
  "recordId": "K251042",
  "nameOrDevice": "AI-Assisted Cardiac Ultrasound System",
  "applicantOrCompany": "MedTech Innovations Inc.",
  "decisionOrStatus": "Substantially Equivalent (SESE)",
  "date": "2026-09-18",
  "productCode": "IYN",
  "stateOrCountry": "US"
}
```

***

### AI Agent & MCP Server Integration (Claude, Cursor, n8n, Make)

This Actor is natively compatible with the **Apify Model Context Protocol (MCP) Server** (https://mcp.apify.com).

- **Claude Desktop / Cursor / Windsurf**: Add this Actor to your MCP configuration to allow autonomous AI Agents to query live structured data on demand.
- **n8n / Make / Zapier**: Trigger this Actor on a daily or hourly cron schedule and pipe the clean JSON dataset directly into your CRM, PostgreSQL, Supabase, or Slack alerts.

***

### Explore the Complete acer_quant_ai B2B Intelligence Suite

Build end-to-end automated pipelines by combining our pure-HTTP, ultra-low-cost (128MB RAM) MCP Actors:

- **E-Commerce & Retail Spy**: [Shopify Store & Product Catalog Spy](https://apify.com/acer_quant_ai/shopify-catalog-spy-mcp) | [WooCommerce & WordPress JSON Spy](https://apify.com/acer_quant_ai/woocommerce-and-wordpress-json-spy-mcp)
- **B2B Hiring & Salary Intelligence**: [Greenhouse Tech Jobs Spy](https://apify.com/acer_quant_ai/b2b-tech-jobs-and-hiring-spy-mcp) | [Ashby HQ AI Unicorn Jobs & Equity](https://apify.com/acer_quant_ai/ashby-ai-jobs-salary-equity-mcp) | [Rippling v2 & Lever Salary Scraper](https://apify.com/acer_quant_ai/rippling-lever-ats-salary-mcp)
- **Healthcare, MedTech & Biotech Leads**: [US Doctors & Clinics NPI Registry v2.1](https://apify.com/acer_quant_ai/us-doctors-and-medical-npi-registry-scraper-mcp) | [openFDA 510(k) Devices & Drug NDC](https://apify.com/acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp) | [NIH ClinicalTrials.gov v2 Biotech Contacts](https://apify.com/acer_quant_ai/clinicaltrials-biotech-leads-mcp)
- **SaaS, GovTech & PropTech**: [USASpending Federal Contract Winners](https://apify.com/acer_quant_ai/usaspending-federal-contracts-mcp) | [Atlassian Marketplace v3 SaaS Spy](https://apify.com/acer_quant_ai/atlassian-marketplace-v3-b2b-spy-mcp) | [WordPress Plugin Micro-PE Leads](https://apify.com/acer_quant_ai/wordpress-plugin-pe-leads-mcp) | [VS Code Marketplace Trending DevTools](https://apify.com/acer_quant_ai/vscode-marketplace-devtools-mcp) | [European Real Estate Listings](https://apify.com/acer_quant_ai/europe-realestate-listings-mcp)
- **AI Data Utilities & AEO**: [LLM HTML/CSV Table Cleaner & llms.txt Auditor](https://apify.com/acer_quant_ai/llm-table-cleaner-and-auditor) | [Website AEO, Schema.org & AI Crawler Auditor](https://apify.com/acer_quant_ai/aeo-seo-and-ai-crawler-auditor-mcp)

# Actor input Schema

## `datasetType` (type: `string`):

Choose between 510(k) Medical Device Clearances, Drug NDC Directory, or Device Recalls

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

Leave empty for latest records, or enter FDA search syntax (e.g. applicant:Medtronic)

## `maxItems` (type: `integer`):

Total number of FDA records to extract

## Actor input object example

```json
{
  "datasetType": "device_510k",
  "searchQuery": "",
  "maxItems": 50
}
```

# Actor output Schema

## `overview` (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 = {};

// Run the Actor and wait for it to finish
const run = await client.actor("acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp").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("acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp").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 acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,acer_quant_ai/openfda-510k-medical-device-and-drug-ndc-mcp"
        }
    }
}
```

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/gacllOVa5fgHdey4H/builds/bwuobxpatUMouG3sv/openapi.json