65 results · 17ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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