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Index/Organizations/Center for Devices and Radiological Health

Center for Devices and Radiological Health

Center of the U.S. Food and Drug Administration

Fact-Checks

3 results
Dec 17, 2025
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What 510(k) records or FDA device listings exist for Encore Medical vacuum erection devices and what are their clearance dates?

A targeted review of the provided reporting finds vendor product pages describing Encore-branded vacuum erection devices and general FDA 510(k) guidance pages, but the reporting does not include any s...

Jan 13, 2026

Which regulatory bodies have evaluated neurodefender and is it FDA-approved?

The documents supplied describe how the U.S. Food and Drug Administration regulates neuromodulation and neurological devices—outlining pathways such as 510(k), De Novo, Premarket Approval (PMA), Human...

Nov 22, 2025

What FDA authorizations or 510(k)/PMA submissions has Neurocept Inc. made by 2025?

Available sources do not report any FDA authorizations, 510(k) clearances, or PMA submissions specifically attributed to Neurocept Inc. through 2025; searches of the provided FDA and trade-report docu...