BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    PX COULTER(R) CELL CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYRINGE 50ML 18G 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·September 25, 2020

    OASYS SURGICAL LIGHT CONTROLLER

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

    LIVESURE BARBITURATES SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 11, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 2, 2010

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    GRYPHON P BR DS ANCHOR W/OC

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·January 23, 2019

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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