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FDA 510(k) & PMA Device Clearances: Medical Device Approvals

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FDA medical device 510(k) clearances and PMA approvals: applicant, contact person, address, device and generic name, product code, specialty, device class, dates received and decided, review days, decision and links. Filters by date, company, device, product code, specialty, class; alerts.

Pricing

from $3.20 / 1,000 decisions

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0.0

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Developer

Tapaswai Choudhary

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Monthly active users

4 days ago

Last modified

FDA 510(k) & PMA Device Clearances — Medical Device Approvals

New FDA medical device decisions in one clean feed: 510(k) clearances and PMA approvals, each with the applicant company, the contact person (510(k)), address, device and generic name, product code, review specialty, device class, dates received and decided, review time in days, decision and links to the FDA record and summary.

Built for medtech sales and business development (newly cleared devices = companies about to launch), regulatory consultants, contract manufacturers and component suppliers, investors and analysts, and AI agents.

What you get

Field	Meaning
`type`, `id`, `url`, `documentUrl`	510(k) / PMA, its number and FDA links
`applicant`, `contact`, `street`, `city`, `state`, `zip`, `country`	Who got it and how to reach them
`deviceName`, `genericName`, `productCode`, `deviceClass`, `regulationNumber`, `specialty`	The device
`dateReceived`, `decisionDate`, `reviewDays`, `decision`, `submissionType`	The review
`approvalStatement`, `supplementReason`	PMA details

Why this Actor

Both pathways in one schema, newest first.
Filters: date window, company, device words, product codes, specialty, device class; PMA supplements on request.
Alerts: Only new decisions on a weekly schedule.
For AI agents. Callable as an MCP tool.

How to use it

New cardiovascular and radiology clearances this month:

{ "types": ["510k"], "decidedWithinDays": 30, "specialties": ["Cardiovascular", "Radiology"] }

Pricing

$4 per 1,000 decisions plus a small start fee per run. On the Apify free plan a run returns up to 100 decisions.

Good to know

Data is as published by FDA through openFDA. Questions: tacps126@gmail.com.

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