BEUDAMED
    2,451 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID BRAF KIT

    Aid, Surgical, Viscoelastic

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID™-BRAF

    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

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS FREE PSA RT ASSAY

    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

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·IN MOTION LUMBAR ARTIFICIAL DISC

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS

    Stimulator, Electrical, Implantable, For Incontinence

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

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

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