1,034 results · 18ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE XVE LVAS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES

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 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

Ventricular (Assist) Bypass

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·TCI HEARTMATE IP LVAS

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