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$50.00 / 1,000 device records

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Medical Device Records — FDA 510(k) & PMA API

Try for free

Track FDA medical device 510(k) clearances and recalls from official openFDA data: applicant, device, product code, class, decision date, and Class I/II/III recall severity. For medtech intelligence.

Pricing

$50.00 / 1,000 device records

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NexGenData

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Medical Device Records

FDA medical-device records — 510(k) clearances and device recalls (enforcement reports) with product codes and dates.

Public regulatory/health data — not medical advice.

📊 What you get

Clean JSON, one record per record (full output has 15 fields):

record_type — Record type
applicant — Applicant
device_name — Device name
identifier — Identifier
decision_date — Decision date
decision — Decision
clearance_type — Clearance type
product_code — Product code
advisory_committee — Advisory committee
device_class — Device class

Pricing: $0.05 per record (Pay-Per-Event) — about 20 records per $1. Only records actually delivered to the dataset are charged; empty runs and runs that fail because openFDA is unreachable charge nothing for the missing rows.

▶️ How to run it

Pick at least one data_types value (clearances, recalls), optionally an applicant/firm and a lookback_days window. With no data_types the run succeeds with 0 records and names the missing field.

🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.

Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

FDA & public-health records family:

OpenFDA Drug · Drug Approvals · Drug Shortages · Purple Book · Warning Letters/483 · Pharma Pipeline · Adverse Events

Product-safety recalls: NHTSA Recalls · NHTSA Defects · NHTSA Safety · CPSC Recalls

Agent front door — Healthcare & FDA MCP: Healthcare & FDA MCP

This actor is currently private — treated and ready for review.

Public official records and enforcement data, assembled for research and monitoring.

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