BEUDAMED
    7 results · 38ms · Sources: EU EUDAMED, US FDA

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    OPTI LITE

    FDA Adverse Event
    Malfunction ·XINTEC CORP.·Product code GEX·July 26, 1995

    ROTALASE

    FDA Adverse Event
    Malfunction ·XINTEC CORP.·Product code LNK·March 30, 1998

    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

    FDA Recall
    Terminated ·Xintec Corp·Product code GEX·October 29, 2017

    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.

    FDA Recall
    Terminated ·Xintec Corp·Product code GEX·June 23, 2017

    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

    FDA Enforcement
    Class III ·Terminated·Xintec Corp·October 30, 2019

    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.

    FDA Enforcement
    Class II ·Terminated·Xintec Corp·August 9, 2017

    OPEN MIND LABORATORY LTD

    Importer
    🇷🇴 Romania·11 Manufacturers