Mani, Inc. - Kiyohara Facility

FDA Regulatory Profile

Mani, Inc. - Kiyohara Facility appears in FDA public data with 3 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1468-2023, Class II) was initiated on February 20, 2023.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1468-2023Class IIMani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterileFebruary 20, 2023
Z-0557-2021Class IIMANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular October 27, 2020
Z-0558-2021Class IIMANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraoOctober 27, 2020