2,326 results · 20ms · Sources: EU EUDAMED, US FDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® AED G3 Pro

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PRO-Kinetic Energy Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve, Evolut-R Evolut PRO

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon PanOptix Pro Trifocal IOLs

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·ABSOLUTE PRO VASCULAR STENT SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut R, PRO Bioprosthesis

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® G3 Pro AED

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut R and Evolut PRO

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut PRO+ Delivery Catheter System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut PRO System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut PRO Transcatheter Aortic Valve; Evolut PRO+ Transcatheter Aortic Valve; Evolut FX Transcatheter Aortic

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve™ EnVeo™ R Delivery Catheter System, CoreValve™ EnVeo™ PRO Delivery Catheter System, Evolut™ PRO+ Delivery Cath

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter