BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMOND AF

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·X-STOP IPD SYSTEM

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·XACT CAROTID STENT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2100 SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Refyne, Restylane Defyne

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·CyPass System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INTRATHECAL CATHETERS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

    Lens, Intraocular, Accommodative

    FDA Pre-Market Approval
    FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·Invenia ABUS Autoated Breast Ultrasound System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID Implantable Infusion Pump and Accessories

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

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp™ Unidirectional Ablation Catheter, Small Curve, DiamondTemp™ Unidirectional Ablation Catheter, Large Curve,

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M

    Stimulator, Electrical, Implantable, For Incontinence

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