BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    LAKE FOLEY CATHETERIZATION TRAY

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

    NA

    FDA UDI
    STERIS CORPORATION·10724995152465·The Vis-U-All High Temperature Heat Seal Steril...

    Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

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

    FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    SYSTEM 6 ASEPTIC HOUSING ASSY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 19, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·October 26, 2010

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 21, 2012

    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·December 2, 2020

    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 13, 2021

    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·March 7, 2018