BEUDAMED
    2,328 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·Wave Light EX500 Laser

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·ENLITE GLUCOSE SENSOR, ENLITE SERTER

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL AND PROPEL MINI SINUS IMPLANTS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS TORIC CALCULATOR

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·MENICON SF-P (MELAFOCON A) CONTACT LENS

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

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Infinity™ Deep Brain Stimulation (DBS)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG)

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim™ Dorsal Root Ganglion (DRG) IPG

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UROVYSION BLADDER CANCER KIT

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Minerva Endometrial Ablation System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY PULSE GENERATORS

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System with SmartGuard

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim SCS IPG

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)