BEUDAMED
    2,258 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·BARD STINGER ABLATION CATHETERS

    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

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV HR

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP/Impella CP with SmartAssist

    Temporary Non-Roller Type Left Heart Support Blood Pump

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

    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

    Stimulator, Electrical, Implantable, For Incontinence

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

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICAL URINARY SPHINCTER (AUS)

    Device, Thermal Ablation, Endometrial

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

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME(R) ENDOPROSTHESIS

    Laparoscopic Contraceptive Tubal Occlusion Device

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

    Ventricular (Assist) Bypass

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