BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814268·GENUMEDI PT SILVER R III

    RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·December 6, 2021

    MICRUSPHERE MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR·Product code HCG·October 2, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EYB·July 2, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 28, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code EZL·July 8, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·January 15, 2021

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024