BEUDAMED
    136 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Portico™ Transcatheter Heart Valve

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Biocor™, Biocor™ Supra, Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable System for Remodulin

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Voluma XC, Vollure XC, and Juvederm Volbella XC

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphereTM Y-90 Glass Microspheres System

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

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

    FDA Pre-Market Approval
    FDA Class 3 ·Wolverine Coronary Cutting Balloon

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems