BEUDAMED
    37 results · 20ms · 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)

    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

    Lenses, Soft Contact, Extended Wear

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

    Lens, Multifocal Intraocular

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

    ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    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

    Prosthesis, Finger, Constrained, Metal/Polymer

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

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW (-S) BP STEROID-ELUTING LEADS

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW (-S) BP LEFT VENTRICULAR LEADS

    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

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

    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

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System