BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·SPINAL CORD STIMULATION

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, INOGEN, ORIGEN CRT-D'S

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·LATITUDE Wave Communicator Model 6290

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip NTR/XTR System, MitraClip G4System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Epic Vascular Self-Expanding Stent System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA Single-Piece Anterior Chamber Intraocular Lens

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GELSYN-3

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter