ClearanceBrief
Company · US

AURIS HEALTH INC

FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (1 in 12 months)
8recalls (2 in 12 months)
8recalls that name a 510(k)

Product codes

CodeDeviceRecords
EOQBronchoscope (Flexible Or Rigid)10
FGBUreteroscope And Accessories, Flexible/Rigid2
QNWReprocessed Bronchoscope1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 25, 2026K260382MONARCH™ Platform (MON-000008)
Auris Health, Inc.
EOQ
Jan 23, 2025K243219MONARCH™ Platform (MON-000008)
Auris Health, Inc.
EOQ
Apr 29, 2022K213334Monarch Platform, Urology
Auris Health, Inc.
FGB
Jul 9, 2021K211493Monarch Platform
Auris Health, Inc.
EOQ
Apr 15, 2020K193534Monarch Platform
Auris Health, Inc.
EOQ

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 17, 2026Auris Health, Inc
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Open, Classified		 EOQK193534
K211493 +1
Nov 19, 2025Auris Health, Inc
MONARCH Bronchoscope. Model Number: MBR-000211-B
Open, Classified		 QNWK231473
Oct 10, 2024AURIS HEALTH INC
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Open, Classified		 FGBK213334
Oct 10, 2024AURIS HEALTH INC
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Open, Classified		 EOQK211493
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Open, Classified		 EOQK193534
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Open, Classified		 EOQK193534
Dec 1, 2023AURIS HEALTH INC
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Open, Classified		 EOQK193534
Apr 19, 2019AURIS HEALTH INC
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Terminated		 EOQK173760
Get alerts for these product codes