BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    U by Kotex Click Unscented Menstrual Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

    U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

    SteriLance Impress safety lancet 21G 1.8mm

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630123303·

    STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SNORE GUARD ADVANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    STERISEAL 27G HYDRODISSECTION VE CURVED .40MM X 22MM CANNULA

    FDA Adverse Event
    Injury ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code HMX·July 20, 2017

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 5, 2013

    COULTER LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 15, 2011

    PROGRAMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 18, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024