BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    MIM 4.1 (SEASTAR)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Rear Delivery

    FDA UDI
    Engle Dental Systems, LLC·00850043433064·Under cabinet mount AS-1 Delivery

    INSIGHT MILLENNIUM PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·August 4, 2023

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 22, 2013

    ARCHITECT I1000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·April 28, 2011

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018