1,331 results · 18ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

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

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 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DEMA, DIVA AND AFM PULSE GENERATORS

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 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; /

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PROTOS DR/CLS AND PROTOS VR/CLS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

Ventricular (Assist) Bypass

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

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Tendril STS 2088TC Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG (R)MODEL 3039 FUNCTION PACK

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR/INTEGRITY SR

Ventricular (Assist) Bypass

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