BEUDAMED
    46 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

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

    Implant, Cochlear

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

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCYTE (DERMAGRAFT-TC)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

    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, Cochlear

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

    Implant, Cochlear

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bip

    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)

    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) and Accessories

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine samaritan Public Access Automated External Defibrillators and Accessories

    Automated External Defibrillators (Non-Wearable)

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

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories