BEUDAMED
    213 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Mosaic Bioprosthesis

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX PROCEDURAL KIT

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TRIFECTA VALVE

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCOR/EPIC VALVE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD

    Agent, Occluding, Vascular, Permanent

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

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·STARR EDWARDS SILASTIC BALL VALVE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without 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

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·GENESYS HTA SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM

    Sealant, Dural

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

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·DBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM