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

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    SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    BEND-SCR F/UNILOCK-RECOPL TI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·June 22, 2013

    ECHELON 45 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 29, 2011

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·August 13, 2021

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 27, 2022

    COONS DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 28, 2022

    PHOTOFIX PATCH - 6CM X 8CM

    FDA Adverse Event
    Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020