FDA Device 510(k) Clearances & PMA Approvals
Pricing
$0.30 / 1,000 decisions
FDA Device 510(k) Clearances & PMA Approvals
Every FDA medical device 510(k) clearance and PMA approval or supplement from openFDA. Filter by company, product code, device name, review panel and decision date. Decision and receipt dates on every row.
Pricing
$0.30 / 1,000 decisions
Rating
0.0
(0)
Developer
Pushbuild Data
Maintained by CommunityActor stats
0
Bookmarked
2
Total users
1
Monthly active users
a day ago
Last modified
Share
Every FDA medical device 510(k) clearance and PMA decision, from openFDA, in clean JSON.
What you get
Type (510k or PMA), K or P number, supplement, company, device and generic name, product code, device class, regulation number, medical specialty and review panel, date received and decision date, decision, clearance type, expedited and third-party review flags, location, and a link to the FDA record.
Use cases
- Track clearances and approvals for medtech companies you follow.
- Competitive intelligence by product code (for example every radiology triage software clearance).
- Event studies: decision dates for original PMAs.
Input examples
Notes
- openFDA refreshes device data weekly.
- Pricing: per decision returned.
