BEUDAMED
    11 results · 34ms · Sources: EU EUDAMED, US FDA

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    ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213026872·Flexitron Transfer Tube for Metal Needles (35)

    BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 2, 2023

    GENZYME DIRECT-AMYLASE TEST REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

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

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2022

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013

    PARADIGM REAL-TIME INSULIN INFUSION SET

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011

    NORMAL SALINE

    FDA Adverse Event
    Injury ·BD·Product code NGT·August 12, 2008

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021