BEUDAMED
    2,596 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLilQ System

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure Test

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Programmer System

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX(R)

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEPTEST

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS CHECKMATE SYSTEM

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM