2,311 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Evolut R TAV, Evolut PRO TAV, Evolut PRO+ TAV, Evolut FX TAV
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System