10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag™ Circulatory Support System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus™ Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC10 & PC21

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 530G System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene Cryotherapy Device

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

FDA Pre-Market Approval
FDA Class 3 ·Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer Thermocool NAV Catheter and Navistar Thermocool

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Aortic Root Bioprosthesis

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir VR Leadless System

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

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES