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

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    Q65 MEDICAL TREADMILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534020·CODMAN® HAKIM® Precision Fixed Pressure Valve, ...

    Banded Face Mask

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

    IMAGECHECKER-CT WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    HAKIM PRECISION VALVE, STANDARD

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·April 24, 2007

    PLUM A+ INTERNATIONA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 7, 2012

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·September 1, 2010

    CODMAN BACTISEAL CATHETER KIT

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·February 4, 2021

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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