BEUDAMED
    10,000 results · 39ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Endovascular Graft, Aortic Aneurysm Treatment

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 400 FAMILY OF PACEMAKERS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·COAPTITE injectable implant

    Filler, Bone Void, Non-Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i AFP Assay

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PreveLeak Surgical Sealant & 10pk applictor tips

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip XTR Clip Delivery System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Bioprosthesis

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel)

    Agent, Occluding, Vascular, Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·VenaSeal Closure System

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor MemoryShape Breast Implants