Auris Health, Inc.
Auris Health, Inc. holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2026, with 8 FDA device recalls on record.
Top product codes for Auris Health, Inc.
FDA recalls by Auris Health, Inc.
- Z-1383-2026 — MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- Z-0543-2026 — MONARCH Bronchoscope. Model Number: MBR-000211-B
- Z-0052-2025 — Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
- Z-0051-2025 — Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
- Z-0449-2024 — Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Z-0448-2024 — Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
- Z-0450-2024 — Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
- Z-0025-2020 — Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Auris Health, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.