Auris Health, Inc
7 FDA 510(k) clearances · Recalling firm
| Record | Firm | Date |
|---|---|---|
| MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-0000 recall (Z-1383-2026) | Auris Health, Inc | 2026-02-17 |
| MONARCH Bronchoscope. Model Number: MBR-000211-B recall (Z-0543-2026) | Auris Health, Inc | 2025-11-19 |
| Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronch recall (Z-0051-2025) | AURIS HEALTH INC | 2024-10-10 |
| Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB recall (Z-0052-2025) | AURIS HEALTH INC | 2024-10-10 |
| Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w recall (Z-0448-2024) | AURIS HEALTH INC | 2023-12-01 |
| Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w recall (Z-0449-2024) | AURIS HEALTH INC | 2023-12-01 |
| Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w recall (Z-0450-2024) | AURIS HEALTH INC | 2023-12-01 |
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Every clearance here is in the API, with alerts when new ones post.