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

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    HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668410211·Ready•Steel K-FILE 010 21MM

    RF INTRODUCTION CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    Zimmer, Inc.·00889024193192·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193239·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193208·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193246·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193222·

    NA

    FDA UDI
    Zimmer, Inc.·00889024193215·

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 20, 2012

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·June 12, 2015

    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