BEUDAMED
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    Visix

    FDA UDI
    TELEVERE SYSTEMS, LLC·00851800007054·Visix 8.1 software Build 81

    Visix

    FDA UDI
    TELEVERE SYSTEMS, LLC·00851800007047·Visix Pro software version 7.7.15

    Visix

    FDA UDI
    TELEVERE SYSTEMS, LLC·00851800007030·Visix software version 2.3.9

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

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

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

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

    Automated Insulin Dosing , Threshold Suspend

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

    Stent, Urethral, Prostatic, Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·iWear oxygen and iWear oxygen astigmatism

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    FDA Pre-Market Approval
    FDA Class 2 ·MICROSCAN(R) RAPID FLUOROGENIC PANELS

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

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

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im

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

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive

    N95 Respirator With Antimicrobial/Antiviral Agent

    FDA classification
    FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent

    Surgical Mask With Antimicrobial/Antiviral Agent

    FDA classification
    FDA Class 2 ·Surgical Mask With Antimicrobial/Antiviral Agent