8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·December 13, 2023
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA Enforcement
Class II
·Terminated·AURIS HEALTH INC·November 27, 2019
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025