BEUDAMED
    10,000 results · 53ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst

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

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramic TRANSCEND® Hip Articulation System

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Saline-Filled and Spectrum Breast Implants

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS Therapy System

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·lnterStim Therapy System, Verify Evaluation System (SNS Bowel)

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC™ Ophthalmic Viscosurgical Device

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Urinary)

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·EVIA FAMILY OF PACEMAKERS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Supera Peripheral Stent System, Supera Pro Interwoven Peripheral Stent System

    Implant, Auditory Brainstem

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

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM Septal Occluder

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant