Ellex iScience, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0011-2019Class IIellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The fJanuary 11, 2018
Z-2590-2014Class IIiTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. IndicatedAugust 6, 2014