3 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
FDA Enforcement
Class II
·Ongoing·Noah Medical Corporation·December 3, 2025
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Enforcement
Class II
·Ongoing·Noah Medical·May 8, 2024
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Enforcement
Class II
·Ongoing·Noah Medical·January 1, 2025