10,000 results · 54ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF/ATLAS+HF FAMILY OF CRT-DS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8, MULTI-LINK 8 SV, and MULTI-LINK 8 LL Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM,

Ventricular (Assist) Bypass

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE Xpedition Everolimus Eluting Coronary Stent System, SV (2.25), LL; XIENCE Alpine Everolimus Eluting Coronary Sten

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK/ACCULINK CAROTID STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder (ASO/ASD)

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

FDA Pre-Market Approval
FDA Class 3 ·Tendril and Optisense f Low Voltage Leads

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL EPIC HF SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER