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

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    EntericBio Dx Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BUILD-IT TOTAL CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    MRDH BANDAGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AVANTA FLUID MANAGEMENT SYSTEM

    FDA Adverse Event
    Death ·BAYER MEDICAL CARE, INC.·Product code DXT·July 31, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 22, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    LUPINE DRILL BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HTW·September 25, 2008

    TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020