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_typeapplicantdevice_nameidentifierdecision_datedecisionclearance_typeproduct_codeadvisory_committeedevice_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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