BEUDAMED
    27 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Simplera™ System

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    FDA Pre-Market Approval
    FDA Class 3 ·RESQCPR SYSTEM

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·Resure Sealant

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcon G5 Mobile Continuous Glucose Monitoring System

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    FDA Pre-Market Approval
    FDA Class 3 ·RESQCPR SYSTEM

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    FDA Pre-Market Approval
    FDA Class 3 ·ResQCPR System

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    FDA Pre-Market Approval
    FDA Class 3 ·ResQCPR System