BEUDAMED
    29 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

    Ring, Endocapsular

    FDA Pre-Market Approval
    FDA Class 3 ·Capsular Tension Ring (CTR) and RingJect

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx Downstream System

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID-BRAF KIT

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford® Partial Knee System

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS (R) Total Knee System

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Master Intellis Spinal Cord Stimulation Systems

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)