BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    PARAGON HEMOGLOBIN ELECTRO. REAG. KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008200·STRAIGHT WIRES SPRING HARD 215x28

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    DISCOVRED

    FDA 510(k)
    FDA Class 2 ·Dental

    SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINX REFLUX MGMT SYS

    FDA Adverse Event
    Injury ·TORAX MEDICAL INC.·Product code LEI·May 7, 2014

    ETS FLEX ARTICNG LNR CUTR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 24, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024