10,000 results · 49ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ACCENT PACEMAKERS

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF FAMILY CRT-DS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity DBS Systems

Transcatheter Septal Occluder

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

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

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SJM MRI Activator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI and Endurity MRI

Ventricular (Assist) Bypass

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

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY SR/DR

Implantable Cardioverter Defibrillator (Non-Crt)

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

Implantable Cardioverter Defibrillator (Non-Crt)

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·TRIFECA HEART VALVE

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

FDA Pre-Market Approval
FDA Class 3 ·Quadra Allure™, Quadra Allure MP™

Heart-Valve, Mechanical

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

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

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LVAS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052

Catheter, Coronary, Atherectomy

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ICDS