BEUDAMED
    10,000 results · 39ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HPV Test

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas 4800 BRAF V600 Mutation Test

    Immunocytochemistry Assay, P16/Ki-67

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR Mutation Test v2

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® CARDIOFORM Septal Occluder

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas x 480, cobas HPV Test, 240/960 Tests

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas BRAF V600 Mutation Test

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas® EZH2 Mutation Test

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EFGR Mutation Test, v2.0

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas KRAS Mutation Test

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Cardioform Septal Occluder

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·WaveWriter Alpha Spinal Cord Stimulator (SCS) System

    Artificial Heart

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SPINAL CORD STIMULATION SYSTEMS

    Artificial Heart

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