BEUDAMED
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    Vantage Titan 1.5T, MRT-1510, V3.6 Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

    LUCENT OR LUCENT MAGNUM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELTAFILL18 5MM X 20CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·November 14, 2022

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

    CONTOUR NEXT (CONNECTED)

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

    ENDURANT ILIAC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 6, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 10, 2013

    CENTRICITY RA1000

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·September 1, 2008

    CONTOUR NEXT

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

    CONTOUR NEXT (CONNECTED)

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

    CONTOUR NEXT (CONNECTED)

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017