BEUDAMED
    1,542 results · 38ms · Sources: EU EUDAMED, US FDA

    FDA Pre-Market Approval
    BRACAnalysis CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™

    Dimension Vista® Testosterone Calibrator

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414948775·Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x ...

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne®Liquid CDx (F1LCDx)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne®CDx (F1CDx)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    BLOOD COLLECTION, CAPILLARY TUBES

    Device
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    BUFFERS

    Device
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    Determine

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market