BEUDAMED
    2 results · 50ms · 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 FDA Enforcement ×

    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

    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