BEUDAMED
    897 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 System

    Automated Insulin Dosing Device System, Single Hormonal Control

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

    Sensor, Glucose, Invasive

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC

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

    FDA Pre-Market Approval
    FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

    Digital Breast Tomosynthesis

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS CHECKMATE SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·ARTIFICIAL PANCREAS DEVICE SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)