BEUDAMED
    56 results · 61ms · Sources: EU EUDAMED, US FDA

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    Optilume

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Urotronic, Inc.·1 device

    1434-MDD-033/2021

    Certificate
    MDD Annex II Section 4·Urotronic, Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·6 Basic UDI-DIs

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    GENERAL ELECTRIC AMX 110

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENERAL ELECTRIC AMX II

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENERAL ELECTRIC AMX 110, AMX II AND AMX 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENERAL ELECTRIC AMX 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOBIL C-ARM, REGURBISHED, VARIOUS MODELS

    FDA 510(k)
    FDA Class 2 ·Radiology