10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Ventricular Assist System

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaTip MiFi Open Irrigated

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Ventricular Assist System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta , Syncra and Viva CRT-P

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval
FDA Class 3 ·MENTOR POLYTEF PASTE /FOR INJECTION

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SINGLE CHAMBER PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SPRINT TM MODEL 6942 LEAD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

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

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

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

FDA Pre-Market Approval
FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip G4 Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS 2 MONORAIL AND OVER-THE-WIRE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-EBK PLUS ASSAY