US device clearances
20 510(k) clearances and PMA approvals since 2015
- Acclarent Aera Eustachian Tube Balloon Dilation System K253612 · 19 Feb 2026
- Acclarent Aera Eustachian Tube Dilation System K230742 · 13 Dec 2023
- Trudi® Navigation System V3 (Fg-2000-00) K231862 · 21 Jul 2023
- Trudi Shaver Blade K221037 · 20 Jul 2022
- Next Generation Balloon Dilation System K201115 · 27 Aug 2020
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.