Ellex iScience, Inc.
Medical device manufacturer in Fremont, CA.
0510(k) clearances
0PMA approvals
2recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0011-2019 Class II | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF…Sterility failure found in one of the units in the lot. | 01/11/2018Terminated |
| Z-2590-2014 Class II | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.…One lot may not have been properly sealed, resulting in a non-sterile device. | 08/06/2014Terminated |