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

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·BRYAN Cervical Disc

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Covera™ Vascular Covered Stent

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ZENITH RENU AAA ANCILLARY GRAFT

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·R3 Delta Ceramic Hip System

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK LEAD SYSTEM

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Covera™ Vascular Covered Stent

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Astron Pulsar and Pulsar-18 Stent Systems

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Solesta Injectable Gel

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent inject Trabecular MicroBypass System

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid L24 Cochlear Implant System

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE SYSTEM

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV ASSAY

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Prestiege LP Cervical Disc - Two-Level