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

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·Rotlex IOLA MFD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL CI System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL Cochlear Implant

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL CONCERT IMPLANT

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL Cochlear Implants

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HOSPITAL WEARABLE DEFIBRILLATOR (HWD 1000)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM