BEUDAMED
    1,113 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Somatic Gene Mutation Detection System

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·SmartAblate™ Irrigation Tubing Set

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SENSAR 1-Piece IOL; TECNIS 1-Piece IOL; TECNIS 1-Piece OptiBlue IOL; Preloaded TECNIS 1-Piece IOL

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type-1 System

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 4000 System

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·ExAblate Neuro Thalamotomy

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 4000 (Exablate Neuro)

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 System

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE NEURO THALAMOTOMY

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)