Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list IrriMAX Corporation with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jun 18, 2024: Irrisept Antimicrobial Wound Lavage.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 18, 2024 | Irrisept Antimicrobial Wound LavageK240552 · FRO | 510(k) clearances |
| Sep 22, 2022 | Irrisept Antimicrobial Wound LavageK222804 · FQH | 510(k) clearances |
| May 28, 2021 | Irrisept Antimicrobial Wound LavageK210536 · FQH | 510(k) clearances |
| Dec 14, 2020 | Irrisept Wound Debridement and Cleansing SystemK202222 · FQH | 510(k) clearances |
| Aug 16, 2019 | Irrisept Wound Debridement and Cleansing System. 12 units per case.Class II · Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | Device recalls |
| Feb 4, 2009 | IRRISEPT WOUND CLEANSING SYSTEMK080779 · FQH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
