10,000 results · 41ms · Sources: EU EUDAMED, US FDA

Transcatheter Septal Occluder

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

Stent, Iliac Vein

FDA Pre-Market Approval
FDA Class 3 ·Abre™ Venous Self-expanding Stent Systems Self-expanding Stent System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE/VITATRON EXCELLENCE +

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL TR

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC & INSYNC III CRT-P

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MIRACLIP CLIP DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PRIZM/VITALITY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DISCOVERY/MERIDIAN

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Procine Bioprosthesis

Coronary Drug-Eluting Stent

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

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SLS SPECTRANETICS LASER SHEATHS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Bulkamid Urethral Bulking System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D