BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    Indicator, Sterilization

    FDA classification
    FDA Class 2 ·Indicator, Sterilization

    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    FDA classification
    FDA Class 2 ·Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    Restraint, Patient, Conductive

    FDA classification
    FDA Class 1 ·Restraint, Patient, Conductive

    Ldt, Approved By Nys Clep

    FDA classification
    FDA Not Classified ·Ldt, Approved By Nys Clep

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA classification
    FDA Class 3 ·Leadless Cardiac Resynchronization Therapy (Crt)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA classification
    FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-Crt)

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA classification
    FDA Class 3 ·Implantable Pulse Generator, Pacemaker (Non-Crt)

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA classification
    FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ldt, Unmet Need Within An Integrated Healthcare System

    FDA classification
    FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

    Television Or Monitor, Non-Crt, Non-Medical, Video Display

    FDA classification
    FDA Not Classified ·Television Or Monitor, Non-Crt, Non-Medical, Video Display

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA classification
    FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA classification
    FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    FDA classification
    FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

    FDA classification
    FDA Class 2 ·Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA classification
    FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

    FDA classification
    FDA Class 2 ·System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test