BEUDAMED
    650 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

    Pediatric Esophageal Atresia Anastomosis Device

    FDA classification
    FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA classification
    FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

    Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

    FDA classification
    FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

    Generator, Pulsatile Flow, Cardiopulmonary Bypass

    FDA classification
    FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

    Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

    FDA classification
    FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System