396 results · 19ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·AED Pro Device

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Pro

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Pro

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·CARELINK PRO PC SOFTWARE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance Pro

Aortic Valve, Prosthesis, Percutaneously Delivered

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

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