Official database · FDAFDA 510(k) medical device database
Search 156k FDA 510(k) clearances by device name, K-number, applicant, or product code. Find predicates and review official FDA clearance data for free.
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156k recordssource FDA
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Where these records come from
This database provides free access to official FDA medical device registration data. Use it to research the United States market, understand device classifications, identify registration holders, and analyze competitive landscape. All data is sourced from official FDA records and updated regularly.
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- 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.
- What is the United States medical device registration database?
- The FDA database contains over 156k registered medical devices in United States. It includes device name, K-number, applicant name, product code, medical specialty, device class, clearance date, and decision date.
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