20 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Galaxy Therapeutics, Inc.
Manufacturer
🇺🇸 United States
GALAXY THERAPEUTICS INC.
FDA registration
GALAXY THERAPEUTICS INC.·2 products·🇺🇸 United States
ORBIT GALAXY DETACHABLE COIL SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 14, 2013
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
FDA Adverse Event
Injury
·NOAH MEDICAL CORP.·Product code EOQ·November 24, 2025
GALAXY SYSTEM
FDA Adverse Event
Injury
·NOAH MEDICAL CORP.·Product code EOQ·September 24, 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 Recall
Open, Classified
·Noah Medical·Product code EOQ·March 9, 2024
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
FDA Adverse Event
Injury
·NOAH MEDICAL CORP·Product code EOQ·December 15, 2025
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 Recall
Open, Classified
·Noah Medical Corporation·Product code EOQ·September 12, 2025
GALAXY SYSTEM
FDA Adverse Event
Injury
·NOAH MEDICAL CORP·Product code EOQ·December 17, 2025
GALAXY SYSTEM
FDA Adverse Event
Injury
·NOAH MEDICAL CORP·Product code EOQ·December 26, 2025
GALAXY SYSTEM
FDA Adverse Event
Injury
·NOAH MEDICAL CORP.·Product code EOQ·March 6, 2026
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Recall
Open, Classified
·Noah Medical·Product code EOQ·October 28, 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
OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code MTD·October 27, 2023
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code NJE·April 25, 2016
Specculo Limited
Authorized representative
🇲🇹 Malta·10 Manufacturers·14 Devices
ICON (LR) Limited
Authorized representative
🇮🇪 Ireland·37 Manufacturers·384 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers