BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    CardioFlux with Faraday Analytical Cloud

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XL EXTRACTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVAULTA SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JTW·December 1, 2017

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code KDT·December 5, 2017

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·October 17, 2014

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 14, 2013

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 5, 2011

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    MALIBU

    FDA Adverse Event
    Injury ·SEASPINE INC.·Product code NKB·February 12, 2020

    MALIBU

    FDA Adverse Event
    Injury ·SEASPINE INC.·Product code NKB·February 12, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018