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

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    IL TOTAL PROTEIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002542·VITROS Chemistry Products Calibrator Kit 99

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)

    ACUMED

    FDA UDI
    Acumed LLC·10806378096327·Lateral Fibula Targeting Block L

    CARDIOBEEPER CB12/12, MODEL CB12/12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOLLYWOOD, PACIFICA, REDONDO, VENTURA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·October 24, 2012

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 17, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017