BEUDAMED
    156 results · 14ms · Sources: EU EUDAMED, US FDA

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    Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

    FDA classification
    FDA Class 2 ·Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

    Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

    FDA classification
    FDA Class 2 ·Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

    Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

    FDA classification
    FDA Class 2 ·Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

    Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

    FDA classification
    FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

    2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

    FDA classification
    FDA Class 2 ·2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    FDA classification
    FDA Class 2 ·Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

    FDA classification
    FDA Class 2 ·Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

    Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

    FDA classification
    FDA Class 2 ·Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

    FDA classification
    FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

    Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

    FDA classification
    FDA Class 1 ·Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

    Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

    FDA classification
    FDA Class 2 ·Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

    Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome

    FDA classification
    FDA Class 2 ·Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA classification
    FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

    FDA classification
    FDA Class 2 ·Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

    FDA classification
    FDA Not Classified ·Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

    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