BEUDAMED
    24 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

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

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SBL-3 Intraocular Lens

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant

    Prosthesis, Finger, Constrained, Metal/Polymer

    FDA Pre-Market Approval
    FDA Class 3 ·SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Lotrafilcon A and B soft contact lenses

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

    Stimulator, Thalamic, Epilepsy, Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Stimulator, Thalamic, Epilepsy, Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC DBS THERAPY FOR EPILEPSY

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense®

    Stimulator, Thalamic, Epilepsy, Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense®

    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

    FDA Pre-Market Approval
    FDA Class 3 ·MAGE-A4 IHC 1F9 pharmDx

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

    FDA Pre-Market Approval
    FDA Class 3 ·MAGE-A4 IHC 1F9 pharmDx

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense