BEUDAMED
    59 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable System for Remodulin

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTAR XL 8 & 10F PVS SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit® PH

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type-1 System