510(k) Ear, Nose, Throat Devices

FDA 510(k) Cleared Ear, Nose, Throat Devices

This page lists all 3778 medical devices in the Ear, Nose, Throat specialty that have been submitted to the FDA through the 510(k) premarket notification process. Hearing aids, cochlear implants, ENT surgical instruments and endoscopes.

• 3762 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 89 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.