1,331 results · 19ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES

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 ·HeartMate II Left Ventricular Assist System

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ELITE II(TM) PULSE GENERATOR

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Ventricular (Assist) Bypass

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS