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

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    Advanced Perfusion System 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100837·FLIERINGA FIXATION RING 22MM

    DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PEDI CO2 EASY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 26, 2023

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 19, 2018

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code GFA·October 9, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 15, 2011

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 1, 2022

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015