BEUDAMED
    91 results · 26ms · 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 ·BIO-RAD MONOLISA ANTI-HBC EIA

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·ICD/CRT PARADYM R AND DR, PARADYM CRT-D, PARADYM RF-VR AND DR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S

    Imager, Breast, Electrical Impedance

    FDA Pre-Market Approval
    FDA Class 3 ·T-SCAN 2000

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S

    Imager, Breast, Electrical Impedance

    FDA Pre-Market Approval
    FDA Class 3 ·TS2000

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM