BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ZARA SOFT TIP CHIN IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756354462·GYN PACK

    THE MAESTRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SILVER ANTIMICROBIAL WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·January 11, 2013

    UNKNOWN MESH PRODUCT (EWHU)

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·November 23, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 2, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015