USA Medical Device Database
Explore FDA 510(k) medical device clearances from 1976 to present. Free search powered by Pure Global AI - search by device name, applicant, product code, or K-number from the official FDA OpenFDA database.
What is the USA FDA 510(k) medical device database?
The FDA 510(k) database contains over 120,000 cleared medical devices in the United States. It includes device names, applicants, product codes, clearance dates, and K-numbers for devices cleared through the 510(k) premarket notification pathway.
How do I search for medical devices in the USA?
Enter a device name, K-number, applicant name, or product code in the search box above. Click search to view results across all FDA 510(k) clearances from 1976 to present.
What information is available for each device?
Each device listing includes: device name, K-number, applicant name, product code, medical specialty, device class, clearance date, and decision date.
Is this database free to use?
Yes, this database is completely free to use. Pure Global AI provides free access to help MedTech companies research the US market and understand FDA clearances.
How often is the database updated?
The database is updated regularly with official FDA OpenFDA data. The current database contains 120,000+ 510(k) clearances from 1976 to present.
What is a 510(k) clearance?
A 510(k) clearance is FDA approval for medical devices that demonstrate substantial equivalence to a legally marketed predicate device. Most Class II devices and some Class I and III devices require 510(k) clearance before marketing in the United States.
About This Database
This database provides free access to official FDA (Food and Drug Administration) 510(k) clearance data. Use it to research the US market, understand device classifications, identify applicants and manufacturers, find predicate devices, and analyze competitive landscape. All data is sourced from the official FDA OpenFDA database and updated regularly.