BEUDAMED
    322 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Gases Used Within Eye To Place Pressure On Detached Retina

    FDA Pre-Market Approval
    FDA Class 3 ·ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

    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, Impella LD, Impella 5.5 with Smart Assist

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

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen LPS-Flex/LPS Mobile Bearing Knee System

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with Smart Assist

    BLOOD GAS EXPERSYSTEM 8700

    FDA 510(k)
    FDA Class 3 ·Unknown

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OMNISCIENCE CARDIAC VALVE PROSTHESIS

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF MONFOCAL/ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES/ACRYSERT DELIVERY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Tupos LV/ATx and Kronos LV-T CRT-D System

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS