BEUDAMED
    2,302 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS

    Organ Care System (Ocs) Heart System

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

    Prosthesis, Penis, Inflatable

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

    Tissue Graft Of 6mm And Greater

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM

    Device, Incontinence, Mechanical/Hydraulic

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

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400

    Tissue Graft Of 6mm And Greater

    FDA Pre-Market Approval
    FDA Class 3 ·Artegraft Collagen Vascular Graft

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Lotus Edge Valve System

    Stent, Carotid

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

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Nuvisc, Anikavisc, Ophthalin

    Ventricular (Assist) Bypass

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

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR

    Dressing, Wound And Burn, Interactive

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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica® IM Alpha Fetoprotein (AFP) Assay