1,198 results · 41ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On-X Ascending Aortic Prosthesis

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MASTERS SERIES COATED AORTIC VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Left Ventricular Assist Device System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE II LVAS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Carbomedics Prosthetic Heart Valve (CPHV)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3 Left Ventricular Assist System