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Auris Health, Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
4
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1383-2026Class IIMONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-0January 21, 2026
Z-0543-2026Class IIMONARCH Bronchoscope. Model Number: MBR-000211-BOctober 18, 2025
Z-0052-2025Class IIMonarch Platform (Urology), REF: MON-000007, MON-000007-RFBAugust 2, 2024
Z-0051-2025Class IIMonarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy)August 2, 2024
Z-0448-2024Class IIMonarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440wOctober 18, 2023
Z-0450-2024Class IIMonarch Platform REF MON-000006 100-240V- 50/60Hz 1440wOctober 18, 2023
Z-0449-2024Class IIMonarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440wOctober 18, 2023
Z-0025-2020Class IIMonarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120April 19, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K243219MONARCH™ Platform (MON-000008)January 23, 2025
K213334Monarch Platform, UrologyApril 29, 2022
K211493Monarch PlatformJuly 9, 2021
K193534Monarch PlatformApril 15, 2020