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

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    MUELLER HINTON AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209113842·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837011994·

    2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTA PLEX ANCA PROFILE

    FDA 510(k)
    FDA Class 2 ·Immunology

    HANDLE WITH MINI QUICK COUPLING

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWX·February 11, 2019

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    UNIVERSAL HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-INAGI·Product code LFL·June 5, 2014

    PUMP IN STYLE BREAST PUMP

    FDA Adverse Event
    Injury ·MEDELA, INC.·Product code HGX·November 23, 2012

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 17, 2015

    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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015