BEUDAMED
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    UNIQUESEA PRODUCTS

    FDA registration
    UNIQUESEA PRODUCTS·1 product·🇹🇭 Thailand

    ENCOR ENSPIRE SYSTM 115V

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·May 13, 2021

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Enforcement
    Class III ·Ongoing·Trackx Technology Inc·November 6, 2024

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·April 17, 2024

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·February 26, 2019

    SAFETRACE TX, REBRANDED AS HORIZON BLOOD BANK

    FDA Adverse Event
    Other ·WYNDGATE TECHNOLOGIES·Product code MMH·April 23, 2009

    OFFSET REAMER HANDLE

    FDA Adverse Event
    Malfunction ·VIANT MEDICAL, LLC·Product code LXH·May 15, 2024

    LEEP SYSTEM 1000 ESU GEN.

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·September 5, 2022

    ZOLL

    FDA Adverse Event
    Injury ·ZOLL MEDICAL CORP·Product code LDD·April 9, 2003

    OFFSET REAMER HANDLE

    FDA Adverse Event
    Malfunction ·VIANT MEDICAL, LLC·Product code LXH·May 5, 2023

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Recall
    Open, Classified ·Trackx Technology Inc·Product code OWB·September 3, 2024