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

    Acute Coronary Syndrome Event Detector

    FDA Pre-Market Approval
    FDA Class 3 ·AngelMed Guardian System

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure Test

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS™) Lung System

    Acute Coronary Syndrome Event Detector

    FDA Pre-Market Approval
    FDA Class 3 ·AngelMed Guardian System

    Acute Coronary Syndrome Event Detector

    FDA Pre-Market Approval
    FDA Class 3 ·Guardian System

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000

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

    FDA Pre-Market Approval
    FDA Class 3 ·Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Senographe Pristina 3D

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·PERFLURON

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)