10,000 results · 26ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Injectable Gel Implants

Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·DETOUR System

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