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

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    VINYL POLYSILOXANE IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    0800,APS1,08,N,TV,CU,CD

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828149570·0800,APS1,08,N,TV,CU,CD

    ACUMED

    FDA UDI
    Acumed LLC·10806378042515·Biotrak® Pin/Helical Nail Tray

    ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYDRO2, HS-75

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023