BEUDAMED
    10,000 results · 34ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin

    Optical Diagnostic Device For Melanoma Detection

    FDA Pre-Market Approval
    FDA Class 3 ·MELAFIND

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·LOTUS Edge Valve System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SJM LEADS

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS)

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·EP Passion Initiative

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Zenith Dissection Endovascular System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM Septal Occluder

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CRYOABLATION CONSOLE

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc IgM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·GEM21S Growth Factor Enhanced Matrix