IrriMAX Corporation

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0191-2020Class IIIrrisept Wound Debridement and Cleansing System. 12 units per case.August 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K240552Irrisept Antimicrobial Wound LavageJune 18, 2024
K222804Irrisept Antimicrobial Wound LavageSeptember 22, 2022
K210536Irrisept Antimicrobial Wound LavageMay 28, 2021
K202222Irrisept Wound Debridement and Cleansing SystemDecember 14, 2020
K080779IRRISEPT WOUND CLEANSING SYSTEMFebruary 4, 2009