factually
Index/Topics/Vacuum Erection Devices FDA Clearance

Vacuum Erection Devices FDA Clearance

The topic is about vacuum erection devices (VEDs) and their FDA clearance status, including the difference between FDA-cleared and FDA-approved devices.

Fact-Checks

4 results
Jan 14, 2026
Most Viewed

Which vacuum erection devices are FDA‑cleared for erectile dysfunction and how do their safety features compare?

Vacuum erection devices (VEDs) have been FDA-cleared for treatment of erectile dysfunction since the early 1980s and are available from multiple manufacturers, but no single, exhaustive list of every ...

Jan 17, 2026
Most Viewed

Which vacuum erection devices appear in FDA 510(k) records and how to search the FDA database for cleared VEDs?

Vacuum erection devices (VEDs) appear in FDA records as Class II external penile rigidity devices with manufacturers and specific models documented in 510(k) summaries and complementary registries; na...

Feb 1, 2026
Most Viewed

Which vacuum erection devices are FDA‑cleared and what warranty/support do major manufacturers offer?

A range of vacuum erection devices (VEDs) are marketed as -cleared or FDA-registered medical devices, but regulatory nuance matters: many VEDs are cleared via 510(k) pathways or are listed on FDA/GUDI...

Jan 12, 2026

Which vacuum erection devices have FDA 510(k) clearances and what do their 510(k) summaries say?

A small set of commercially marketed vacuum erection devices (VEDs) hold FDA 510(k)-era clearances or are registered in federal device databases, but public documentation varies: Imagyn Medical’s Irnp...