BEUDAMED
    4,998 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ER-ICA MONOCLONAL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Cardioverter Defibrillators

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Charger, Model 16000

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT AFP ASSAY

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ellipse, Fortify, Fortify Assura, Quadra Assura MP

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

    FDA Pre-Market Approval
    FDA Class 3 ·Quadra Assura, Unify, Unify Assura, Unify Quadra

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer Septal Occluder

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer Amulet Left Atrial Appendage Occluder

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AFP

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AFP

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

    FDA Pre-Market Approval
    FDA Class 3 ·TactiFlex™ Ablation CatTactiFlex™ Ablation Catheter, Sensor Enabled™heter, Sensor Enabled™, TactiSys™ Quartz Equipment,

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Livewire™ TC XLS™ Ablation Catheter, Livewire™ TC XLS™ Bi-Directional Ablation Catheter, Livewire™ TC Catheter Extension

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

    FDA Pre-Market Approval
    FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™