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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q, CD1257-40, CD1257-40Q, CD2257-40, CD2257-40Q, CD1357-40, CD1357-40C, CD135

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

FDA Pre-Market Approval
FDA Class 3 ·QUARTET CRT LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY,IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

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

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Axium Neurostimulator System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Assurity / Assurity+ / Endurity

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR, XTR and G4 Clip Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE/CURRENT FAMILY OF ICDS

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ACCENT/ZEPHYR/ VICTORY PACEMAKERS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate II LVAS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta Valve with Glide Technology (Trifecta GT)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Coronary Drug-Eluting Stent

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS