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    VISCOT MEDICAL LLC

    FDA registration
    VISCOT MEDICAL LLC·17 products·🇺🇸 United States

    Viscot

    FDA UDI
    Viscot Medical LLC·10848106000992·PLASTIC DRAPE 24 X 36 with 2 3/4" Fenestrati...

    VISCOT

    FDA Adverse Event
    Malfunction ·VISCOT MEDICAL LLC·Product code FTY·September 27, 2023

    VISCOT

    FDA Adverse Event
    Malfunction ·VISCOT MEDICAL LLC·Product code FTY·September 27, 2023

    VISCOT

    FDA Adverse Event
    Malfunction ·VISCOT MEDICAL LLC·Product code FTY·August 31, 2023

    VISCOT

    FDA Adverse Event
    Malfunction ·VISCOT MEDICAL, LLC·Product code FZZ·July 11, 2008

    VISCOT

    FDA Adverse Event
    Malfunction ·VISCOT MEDICAL LLC·Product code FTY·October 11, 2023

    Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Recall
    Terminated ·Viscot Medical LLC·Product code FZZ·August 22, 2012

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Enforcement
    Class III ·Terminated·Viscot Medical LLC·April 10, 2013

    Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.

    FDA Recall
    Terminated ·Medtronic Spine LLC, formerly Kyphon Inc·Product code JDZ·November 10, 2009

    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.

    FDA Recall
    Terminated ·Medtronic Spine LLC, formerly Kyphon Inc·Product code NDN·November 10, 2009