BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    Revi™ System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LCP

    FDA UDI
    Synthes GmbH·10886982164452·4.5MM LCP PROXIMAL TIBIA PLATE 4 HOLES/82MM-LEFT

    rematitan®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011240037000·rematitan® attachment Tapered nut

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTIMUS CMF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 26, 2023

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 29, 2014

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 8, 2011

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LTD·Product code OTN·July 18, 2013