Company ยท US
Irrimax Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2024 | K240552 | Irrisept Antimicrobial Wound Lavage Irrimax Corporation | FRO |
| Sep 22, 2022 | K222804 | Irrisept Antimicrobial Wound Lavage Irrimax Corporation | FQH |
| May 28, 2021 | K210536 | Irrisept Antimicrobial Wound Lavage Irrimax Corporation | FQH |
| Dec 14, 2020 | K202222 | Irrisept Wound Debridement and Cleansing System Irrimax Corporation | FQH |
| Feb 4, 2009 | K080779 | IRRISEPT WOUND CLEANSING SYSTEM Irrimax Corporation | FQH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2019 | IrriMAX Corporation Irrisept Wound Debridement and Cleansing System. 12 units per case. Terminated |
FQH | K080779 |