BEUDAMED
    10,000 results · 150ms · Sources: EU EUDAMED, US FDA

    Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    DUCERAM PLUS CERAMIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40

    FDA 510(k)
    FDA Class 2 ·Dental

    EXCELSIOR PORCELAIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Initial LiSi Block

    FDA 510(k)
    FDA Class 2 ·Dental

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·NMP22 BladderChek Test

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    System, Test, Her-2/Neu, Ihc

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

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT TB TEST

    Immunohistochemistry Assay, Antibody, Folr1

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

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEPTEST

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HPV

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HBV

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Free PSA / Alinity i Free PSA

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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