BEUDAMED
    7,343 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

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

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·enVista hydrophobic acrylic IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

    Inhibitor, Peridural Fibrosis (Adhesion Barrier)

    FDA Pre-Market Approval
    FDA Class 3 ·ADCON -L ADHESION CONTROL IN A BARRIER GEL

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SILIKON 1000

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

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

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA™ System

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ESSURE SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V

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

    FDA Pre-Market Approval
    FDA Class 3 ·CERAMAX Ceramic Total Hip System