BEUDAMED
    2,346 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Implanted Penile Prosthesis

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart® G5 AED

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·Straumann Emdogain

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·SPHINCTER 800 URINARY CONTROL SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·THERMATRX OFFICE THERMOTHERAPY SYSTEM

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·FALOPE RING BAND AND APPLICATOR SYSTEMS

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

    Stent, Urethral, Prostatic, Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·BLU-U

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AUTODELFIA/DELFIA XPRESS HAFP

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP 3000 PROCESSOR

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Complexed PSA (cPSA)