BEUDAMED
    2,856 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

    Artificial Heart

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity m HBV assay

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UPB380S POSTERIOR CHAMBER INTAOCULAR LENSES

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Artificial Heart

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

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

    Artificial Heart

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UB260S

    Artificial Heart

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