BEUDAMED
    2,258 results · 29ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

    Implant, Resorbable, For Articular Osteochondral Repair

    FDA Pre-Market Approval
    FDA Class 3 ·Agili-C

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Automated Impella Controller

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

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

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF

    Tissue Graft Of 6mm And Greater

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

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) 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 SOFTWARE V4.0 SP1 ANTI-HBCT

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM

    Device, Thermal Ablation, Endometrial

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

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx

    Device, Incontinence, Mechanical/Hydraulic

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

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

    Monitor, Intracranial Pressure, Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment

    Temporary Non-Roller Type Left Heart Support Blood Pump

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