BEUDAMED
    4,918 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-SENSOR

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Sensor, Glucose, Invasive

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

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME(R) ENDOPROSTHESIS

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SEN-SERTER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·CARELINK PERSONAL SOFTWARE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS TOTAL PSA

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THxID BRAF assay kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID BRAF KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID™-BRAF

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS FREE PSA RT ASSAY

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS TOTAL PSA ASSAY

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THxID BRAF assay kit