BEUDAMED
    2,671 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

    Prosthesis, Testicular

    FDA Pre-Market Approval
    FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM II INS

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM/INTERSTIM II NEUROSTIMULATOR

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bulkamid Urethral Bulking System

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Liver

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Touch Dispenser

    Light Source System, Diagnostic Endoscopic

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ Photodynamic Diagnostic (PDD) D-Light System

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System.

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·H.E.L.P. PLASMAT FUTURA SYSTEM

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM