BEUDAMED
    2,306 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIATORR TIPSEndoprosthesis product family

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX LEAD

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TAG Thoracic Endoprosthesis product family

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SPRINT QUATTRO LEAD

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·SOLESTA

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SELECTSECURE LEAD

    Transcatheter Septal Occluder

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX MRI LEAD

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·SMARTABLATE™ Irrigation Tubing Set

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Ventricular Assist System

    Enzyme Immunoassay, Fetal Fibronectin

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

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

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

    FDA Pre-Market Approval
    FDA Class 3 ·REFLECTION CERAMIC HIP SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim™ Dorsal Root Ganglion (DRG) IPG