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NexGenData

Posted on • Originally published at thenextgennexus.com

New: Medical Device Records — FDA 510(k) & PMA API — clearances, approvals and recalls from openFDA

What it does

Medical Device Records tracks FDA medical-device activity from official openFDA data: 510(k) clearances, PMA approvals, and device recalls, each with applicant, device name, product code, device class, decision date, and recall severity (Class I/II/III). It turns the FDA's raw regulatory feeds into one clean, queryable record stream for medtech intelligence.

Who it's for

Medtech competitive-intelligence and regulatory-affairs teams tracking rival clearances; investors and analysts watching device pipelines; compliance and quality teams monitoring recalls in their product categories; and journalists covering device safety.

Sample fields / output

Each record is clean JSON with 15 fields, including:

  • record_type
  • applicant
  • device_name
  • identifier
  • decision_date
  • decision
  • clearance_type
  • product_code
  • advisory_committee
  • device_class

Example use cases

  • Competitor watch: monitor new 510(k) clearances and PMA approvals in your product codes to see rivals' pipelines as they clear.
  • Recall monitoring: track Class I/II/III device recalls by applicant or product code for compliance and quality workflows.
  • Market mapping: build a dataset of who is clearing what, in which advisory-committee categories, over time.

Try Medical Device Records on Apify →

Related actors

FAQ

What data sources does it use?

Official openFDA endpoints for 510(k) clearances, PMA approvals, and device recall records — public regulatory data, not medical advice.

How is it priced?

Pay-per-event at $0.150 per record — about 7 records per $1, no subscription.

Does it work with AI agents?

Yes — Claude, the OpenAI Agents SDK, n8n, or any MCP-aware client can call it on demand, and it supports x402 agentic payments in USDC.

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