Auris Health, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Auris Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MONARCH™ Platform (MON-000008), Monarch Platform, Urology, Monarch Platform
5
Total
5
Cleared
0
Denied
Auris Health, Inc. has 5 FDA 510(k) cleared medical devices. Based in Redwood, US.
Latest FDA clearance: Jul 2026. Active since 2020. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Auris Health, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Auris Health, Inc.
5 devices
Cleared
Jul 25, 2026
MONARCH™ Platform (MON-000008)
Ear, Nose, Throat
170d
Cleared
Jan 23, 2025
MONARCH™ Platform (MON-000008)
Ear, Nose, Throat
108d
Cleared
Apr 29, 2022
Monarch Platform, Urology
Gastroenterology & Urology
205d
Cleared
Jul 09, 2021
Monarch Platform
Ear, Nose, Throat
57d
Cleared
Apr 15, 2020
Monarch Platform
Ear, Nose, Throat
117d