BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    SilentCloud

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

    KaiBiLi Extended ViralTrans Saline

    FDA UDI
    Hangzhou Genesis Biodetection & Biocontrol Co., LTD.·16972698600521·5 mL

    SENSUA!

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

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

    NOVUM IQ

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025

    ESSURE

    FDA Adverse Event
    Malfunction ·CONCEPTUS, INC.·Product code HHS·October 23, 2008

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 15, 2013

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·August 23, 2011

    LINA BIPOLAR LOOP, LARGE

    FDA Adverse Event
    Injury ·LINA MEDICAL APS·Product code HIN·October 21, 2024

    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 21, 2022

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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