BEUDAMED
    2,346 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP PROCESSORS

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·AVITENE(R) NON-WOVEN WEB

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

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

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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

    Device, Thermal Ablation, Endometrial

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

    Prosthesis, Penis, Inflatable

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

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·ENTERYX PROCEDURE KIT

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone™

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Orbera Intragastric Balloon System

    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 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC (HYLAN G-F 20)

    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 System

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx