BEUDAMED
    499 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERION INTERSPINOUS SPACER

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant II/IIs Stent Graft System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONATA TI 100 COCHLEAR IMPLANT

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTION ctDx FIRST

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

    Telescope, Implantable, Miniature

    FDA Pre-Market Approval
    FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

    Optical Diagnostic Device For Melanoma Detection

    FDA Pre-Market Approval
    FDA Class 3 ·MELAFIND

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

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

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

    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 ·FoundationOne Liquid CDx (F1 Liquid CDx)

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx