BEUDAMED
    2,487 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·PREVELLE SILK

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·Bond™ Oracle™ HER2 IHC System

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF (GRAFTSKIN)

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

    Device, Incontinence, Mechanical/Hydraulic

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

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·COEASE SODIUM HYALURONATE

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·ANIKA VISC

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM anti-HBc Total (HBcT)

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC & SYNVISC-ONE

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Implantable/Inflatable Penile Prosthesis with and without InhibiZone Treatment

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur and Atellica IM HBc Total

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V