BEUDAMED
    2,762 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON NEOSPHINCTER

    Prosthesis, Penis, Inflatable

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

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOMEMS HF SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·Novoste™ Beta-Cath™ System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line / Implantable Penile Prosthesis with and without InhibiZone Treatment

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Ophthaalmic Viscoelastic

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

    Device, Incontinence, Mechanical/Hydraulic

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

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

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) AND AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIR STENT DELIVERY SYSTEMS

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·Beta-Cath System

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC HYLAN G-F 20