BEUDAMED
    21 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Classification × Regulation: Us FDA × Clear all

    Rinse, Oral, Antibacterial (By Physical Means)

    FDA classification
    FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

    Prosthesis, Testicle

    FDA classification
    FDA Class 3 ·Prosthesis, Testicle

    Tube, Tracheostomy (W/Wo Connector)

    FDA classification
    FDA Class 2 ·Tube, Tracheostomy (W/Wo Connector)

    Injector, Vertebroplasty (Does Not Contain Cement)

    FDA classification
    FDA Class 1 ·Injector, Vertebroplasty (Does Not Contain Cement)

    Hemodialysis Tray (Not A Start/Stop Kit)

    FDA classification
    FDA Class 2 ·Hemodialysis Tray (Not A Start/Stop Kit)

    Internal Polymerase Chain Reaction Control, Not Assay Specific

    FDA classification
    FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

    Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

    FDA classification
    FDA Not Classified ·Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

    FDA classification
    FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    FDA classification
    FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    Prosthesis, Breast, External, No Adhesive

    FDA classification
    FDA Class 1 ·Prosthesis, Breast, External, No Adhesive

    Material, External Aesthetic Restoration, No Adhesive

    FDA classification
    FDA Class 1 ·Material, External Aesthetic Restoration, No Adhesive

    Cpr Aid Feedback Device (No Software)

    FDA classification
    FDA Class 2 ·Cpr Aid Feedback Device (No Software)

    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

    FDA classification
    FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

    Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

    FDA classification
    FDA Class 2 ·Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

    High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

    FDA classification
    FDA Not Classified ·High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    FDA classification
    FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    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

    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

    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

    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

    FDA classification
    FDA Class 2 ·Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained