3 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·October 26, 2022
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 (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