BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mizzy Millennium

    FDA UDI
    Keystone Industries·H66860100481·Denture Acrylic QC Liquid

    NA

    FDA UDI
    Stryker GmbH·03700586902947·Cannulated T25 Screwdriver Shaft

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0100080·Caddie Lid, Implants and Instruments

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·February 5, 2026

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025

    SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIGHT BOND (QUICK CURE)

    FDA 510(k)
    FDA Class 2 ·Dental

    *

    FDA Adverse Event
    Malfunction ·CHURCHILL MEDICAL SYSTEMS, INC. CUSTOM TRAY DIV.·Product code FMI·June 13, 2001

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 11, 2025

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 11, 2011

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 14, 2025

    BD SMARTSITE 13MM VIAL ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·February 27, 2025

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014