BEUDAMED
    673 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Surpass Elite Flow Diverter System

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VITRAX SODIUM HYALURONATE

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·META DDDR PACING SYSTEM

    Pump, Infusion, Implanted, Programmable

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

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTATRON

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·PEPGEN P-15

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM

    Solution, Removal, Carries

    FDA Pre-Market Approval
    FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS FREE PSA RT ASSAY

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    FDA Pre-Market Approval
    FDA Class 3 ·PROGENSA PCA3 ASSAY

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AFP RIA KIT