BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPECIMAN CUP & EMESIS BASIN

    FDA 510(k)
    FDA Class 1 ·Pathology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198505·AK3 Ultra Insert Trial Size 2, 11mm

    SoundBite Console, SoundBite Active Wire 18

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHESAPEAKE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 12, 2012

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 13, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·August 10, 2010

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·April 18, 2025

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code EZL·February 21, 2025

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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