Panels › Gastroenterology, Urology › Product code MSE · Class 2
Hemodialyzer, Re-Use, Low Flux
Regulation 876.5820
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MSE
| Company | 510(k)s | Recalls |
|---|---|---|
| Asahi Medical Co., Ltd. | 2 | 2 |
| Baxter Healthcare Corp | 3 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| Fresenius Medical Care North America | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing o Terminated |
MSE | K983720 |
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of Terminated |
MSE | K983720 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.