BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    Granudacyn® Wound Irrigation Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    Air Bubble Based Infuser (ABBI)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CENTRICITY PACS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 11, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 23, 2013

    TMC SPEEDMTP

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016