510kDecisions.com

Welcome to 510kDecisions.com

This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U.S. Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances. Additionally, we have provided convenient cross-linking of records by applicant company name, contact name, device classification, and product code.

Things You Can Do With This Website:

Sample FDA 510(k) Status Record



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact