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

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    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs / Elecsys HBs II

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·14026704754875·

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334009120·Otis bougie-a-boule. stainless steel

    Hexalobe Driver

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039875·

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 7, 2022

    REMY Medical Therapy Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 18, 2025

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·Raindrop Near Vision Inlay

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014