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

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Foldable Acrylic IOL with OptiEdge

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SENSAR® Soft Acrylic Posterior Chamber IOL

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex ArtificialIris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

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

    FDA Pre-Market Approval
    FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

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

    FDA Pre-Market Approval
    FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

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

    FDA Pre-Market Approval
    FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

    Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFLOW(TM)

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IBI THERAPY ABLATION CATHETERS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IBI CARDIAC ABLATION SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·ITREL 3, SOLETRA, DCI (SYNERGY)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IBI THERAPY CARDIAC ABLATION SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)