2,274 results · 21ms · Sources: EU EUDAMED, US FDA

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·DUETT PRO SEALING DEVICE (MODEL 1010) AND DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·DUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE AND D-STAT FLOWABLE HEMOSTAT

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, Medtroni

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, Medtroni

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, Medtroni

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)

Aortic Valve, Prosthesis, Percutaneously Delivered

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

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