BEUDAMED
    43 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare™ HVAD™ System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 530G Insulin Pump

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Paradigm Real-Time Revel Insulin Pump & Paradigm Real-Time Insulin Pump.

    Sensor, Glucose, Invasive

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

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Butylated Hydroxytoluene (BHT)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE FIREFLY (ADULT)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE FIREFLY (PEDIATRIC)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL® Absorbable Hemostats

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine’s Samaritan® Public Access Automated External Defibrillators

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)