BEUDAMED
    991 results · 31ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MemoryGel Enhance Breast Implants

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System

    Aortic Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Minima Stent System

    Ventricular (Assist) Bypass

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

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

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

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp Ablation System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MemoryGel Enhance Silicone Breast Implants

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY+

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA® Redensity, RHA® Redensity Mepi

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE SP NOVUS LEAD MODEL 5594

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM II, MODEL 3058 NEUROSTIMULATOR

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

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