BEUDAMED
    10,000 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Dna Detection, Human Papillomavirus

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

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Prometra Programmable Infusion Pump System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Eureka!™ Monthly (samfilcon A) Contact Lenses

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES

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

    FDA Pre-Market Approval
    FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·COMBI 40+ Cochlear Implant System

    Implant, Auditory Brainstem

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus ABI541 Auditory Brainstem Implant

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (with and without InhibiZone); AMS 700 Inflatable Penile Prosthesis (with and witho

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR CATHETER, INTERFACE CABLES

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·NOVATION CERAMIC AHS

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

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

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i Anti-HBc

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion (DRG) System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL