Panels › Gastroenterology, Urology › Product code QAX · Class 2
Hemodialyzer With Expanded Solute Removal Profile
Regulation 876.5862
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 1 | 0 |
| Nipro Medical Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2026 | K261399 | ELISIO-HX Nipro Medical Corporation | QAX |
| Aug 28, 2020 | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation | QAX |
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