BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))

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

    ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nordiwell Medical Face Mask

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

    GII C/R ART INS SZ 7-8 9MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019

    HEPARIN IV FLUSH SYRINGE

    FDA Adverse Event
    Malfunction ·MEDEFIL, INC.·Product code NZW·November 6, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·August 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020