6 results
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7ms
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Sources: EU EUDAMED, US FDA
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
FDA Enforcement
Class II
·Ongoing·Moberg Research, Inc.·April 12, 2023
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Enforcement
Class II
·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025
Accure Laser System, Model: PFMS00004
FDA Enforcement
Class II
·Ongoing·Accure Acne, Inc·January 31, 2024
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
FDA Enforcement
Class II
·Ongoing·Hologic Inc·July 24, 2024
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
Bodor P and C series laser cutting machines
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·January 29, 2025