10,000 results · 46ms · Sources: EU EUDAMED, US FDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·QUICKFLEX OF LEFT HEART LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·FORTIFY FAMILY OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire

Ventricular (Assist) Bypass

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·TriClip™ G4 Clip Delivery System

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF SYNCHRONY TRILOGY AND AFFINITY FAMILY OF PACEMAKERS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·DURATA FAMILY OF LEADS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM