BEUDAMED
    1,479 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·Total Artificial Heart

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM AFP

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·Floseal hemostatic Matrix

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Coseal Surgical Sealant

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AXSYM AFP

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT

    Test, Anti-Tumor Cell Susceptibility

    FDA Pre-Market Approval
    FDA Class 3 ·BARTELS CHEMORESPONSE ASSAY

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

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

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

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA COMPANION 2 DRIVER SYSTEM