BEUDAMED
    947 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre 14 Day Flash Glucose Monitoring System

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·Raindrop Near Vision Inlay

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)

    Scaffold, Infrapopliteal, Absorbable

    FDA Pre-Market Approval
    FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Spiration Valve System

    Lymph Node Location System During Sentinel Biopsy Procedure

    FDA Pre-Market Approval
    FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Tendril MRI

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·OrganOx metra® System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Radiesse Injectable Implant

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Hydrus Microstent

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·Linx Reflux Management System

    Intrasaccular Flow Disruption Device

    FDA Pre-Market Approval
    FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

    Telescope, Implantable, Miniature

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Miniature Telescope (IMT)

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device with Shield Technology

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    FDA Pre-Market Approval
    FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·SMART-MSP