BEUDAMED
    714 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Saluda Medical Evoke SCS System

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·SCS Neurostimulators Implantable Itrel Family/Restore Family

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·DBS Neurostimulator Implantable/Activia Family

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·SNS Bowel Neurostimulator/Implantable InterStim

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Implantable Collamer Lens

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Drug Delivery Infusion Pump/SynchroMed

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

    Automated Insulin Dosing Device System, Single Hormonal Control

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

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASOSEAL (TM)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·SNS Urinary Neurostimulator/Implantable InterStim

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Guardian™ Connect system

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTMATE II LVAS