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

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS®) Liver™

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS®) Liver™

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIO OC/SV OTW STENT DELIVERY SYSTEMS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM

Organ Care System (Ocs) Heart System

FDA classification
FDA Class 3 ·Organ Care System (Ocs) Heart System