BEUDAMED
    2,273 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Talisman™ PFO Occluder

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·The 4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

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

    FDA Pre-Market Approval
    FDA Class 3 ·Sangia Total PSA Test

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER PFO OCCLUDER

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·ABSOLUTE PRO, ABSOLUTE PRO LL

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut R, Pro and Pro+ Systems

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R, PRO, PRO+ Systems

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R/PRO/PRO+ Systems

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay