10,000 results · 43ms · Sources: EU EUDAMED, US FDA

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·HERCULINK ELITE PERIPHERAL STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR PACEMAKERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·QuickFlex u, Quartet

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Ventricular (Assist) Bypass

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LWS, OSR

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Acculink Carotid Stent System

Stent, Coronary

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

Occluder, Patent Ductus, Arteriosus

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD

Occluder, Patent Ductus, Arteriosus

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

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·ANTHEM, FRONTIER II CRT-PS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Tendril ST/STS Steroid Eluting Cardiac Leads

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Amulet (ACP2)

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

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder