65 results
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17ms
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Sources: EU EUDAMED, US FDA
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·January 22, 2014
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013