BEUDAMED
    1,450 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT

    Sensor, Glucose, Invasive

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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·Floseal Hemostatic Matrix

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

    Implant, Cochlear

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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Sensor, Glucose, Invasive

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

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Coseal Surgical Sealant

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE

    Sensor, Glucose, Invasive

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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

    Contrast Media, Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX