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

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    ACCUSOFT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502990·X-RAY INDICATOR WITH MARKERS - ANTERIOR

    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VIEW NT

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025

    STELLARIS 25G VIT CUTTER 6/BX

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013

    LIBERTY DRAIN LINE, LUER TAPER CONNECTOR

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING·Product code KDJ·August 15, 2014

    S-ROM HEAD FEMRL ZIRCONIA 28+0

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code LZO·May 8, 2008

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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