1,331 results · 20ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI Leads

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Medical Adhesive

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR blood pumps with Injection Molded Housing

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS

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 ·HeartWare Ventricular Assist System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Merlin.net™ MN5000

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 ·ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PREVA, PRODIGY, VITATRON AND THERA PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VITATRON(R) DEMA PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CARDIAC PACEMAKER PROGRAMMER & BASE STATION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply SR, Reply DR

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYMPHONY AND ELA RHAPSODY PACEMAKERS