BEUDAMED
    4 results · 34ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Ellex iScience, Inc.·October 10, 2018

    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

    FDA Recall
    Terminated ·Ellex iScience, Inc.·Product code HMX·January 11, 2018

    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

    FDA Recall
    Terminated ·Ellex iScience, Inc.·Product code HMX·August 6, 2014

    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

    FDA Enforcement
    Class II ·Terminated·Ellex iScience, Inc.·September 10, 2014