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

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

    FDA Pre-Market Approval
    FDA Class 2 ·EBK

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

    FDA Pre-Market Approval
    FDA Class 2 ·EBK RIA ASSAY/ETI-EBK

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

    FDA Pre-Market Approval
    FDA Class 2 ·EBK

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700481·GC Initial™ MC Op. Dentin Mod. ODM-2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556702311·GC Initial™ MC Op. Dentin Mod. ODM-2, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867317970·Verbugge Plate Holding Forceps

    ADDITIONAL MODEL TO CANON UNIVERSAL STAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·OSTEO CERAMIC HIP

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 28, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 15, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY