BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    RA-CHECK

    FDA 510(k)
    FDA Class 2 ·Immunology

    ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLASIONOMER FX-II

    FDA 510(k)
    FDA Class 2 ·Dental

    FLOEY CATHETER W TEMP

    FDA Adverse Event
    Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014

    DLT TS CER HD 12/14 40MM +1.5

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code LZO·November 14, 2012

    CARELINK ENCORE

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD·Product code OSR·June 10, 2015

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025