20 results · 35ms · Sources: EU EUDAMED, US FDA

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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