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

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    BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·August 16, 2012

    CUSTODIOL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Calibrate Interbody Systems

    FDA 510(k)

    MALLINKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·August 17, 2010

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·March 14, 2014

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code JWH·November 15, 2012

    PUMP MMT-722RNAH PRDGM V2.4 PK EN RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·September 20, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020