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.

📊 Sample Output

applicant	device_name	identifier	decision_date	decision	clearance_type
Medtronic Xomed, Inc.	ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Bl…	K262235	2026-09-04	Substantially Equivalent	Traditional
Medtronic, Inc.	LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)	K262735	2026-08-28	Substantially Equivalent	Special
Medtronic, Inc.	Affera Integrated Mapping System	K262005	2026-08-21	Substantially Equivalent	Special
Medtronic Ireland	NC Euphora Rapid Exchange Balloon Dilatation Catheter	K261428	2026-08-14	Substantially Equivalent	Traditional
Medtronic, Inc.	VitalFlow Set with Balance™ Biosurface	K261335	2026-07-31	Substantially Equivalent	Traditional
Medtronic Ireland	Euphora Rapid Exchange (RX) Balloon Dilatation Catheter	K261759	2026-07-27	Substantially Equivalent	Traditional

Real rows from run DgYPqJt1fpPvU9NYk on build 0.0.6 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.

⚙️ Sample inputs

This is the Store example input — the same input Apify's automated check runs — so it is proven to return rows on the current build. Paste it into the input form, or send it through the API, CLI or a schedule:

{
  "data_types": [
    "clearances",
    "recalls"
  ],
  "applicant": "Medtronic",
  "lookback_days": 90,
  "max_per_type": 10
}

🔧 Input reference

Field	Type	Default	What it does
data_types	array	["clearances", "recalls"]	Which datasets: clearances (FDA 510(k)) and/or recalls (device enforcement). Required — with none selected the run returns 0 records and charges nothing.
applicant	string	"Medtronic"	Filter to a specific device maker / recalling firm by name (e.g. Medtronic). Empty = all.
lookback_days	integer	90	How far back to pull clearances and recalls.
max_per_type	integer	10	Max records returned per dataset.
include_raw	boolean	false	Attach raw source record.

🧾 JSON sample record

One real record from run DgYPqJt1fpPvU9NYk (emails/phones masked, long text shortened):

{
  "record_type": "510k_clearance",
  "applicant": "Medtronic Xomed, Inc.",
  "device_name": "ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)",
  "identifier": "K262235",
  "decision_date": "2026-09-04",
  "decision": "Substantially Equivalent",
  "clearance_type": "Traditional",
  "product_code": "PGW",
  "advisory_committee": "Neurology",
  "device_class": "2",
  "medical_specialty": "Neurology",
  "classification": null,
  "source": "openFDA 510(k)",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262235",
  "detected_at": "2026-09-25T00:00:36.969572+00:00"
}

💰 Pricing

Event	Price (USD)	When it is charged
Device record (device-record)	$0.05	Charged per device clearance or recall returned.

Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.05 = $5.00 plus the start fee.

🔗 Related Actors

More from the NexGenData Healthcare & FDA family:

• FDA Purple Book — Biologics & Biosimilars API
• FDA Recall Monitor — Drug & Device Safety Alerts
• FDA Warning Letters & 483 Inspections API
• Medicare Provider Records — CMS Doctor Data API
• NPI Healthcare Provider Leads — Doctors & Practices API

16 more in this family on the NexGenData Store page.

📊 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.

🔗 Related regulatory actors

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.