Panels › Gastroenterology, Urology › Product code FII · Class 2
System, Dialysate Delivery, Sealed
Regulation 876.5860
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FII
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Renal Div | 0 | 2 |
| Gambro, Inc. | 2 | 0 |
| Hospal Medical Corp. | 1 | 0 |
| Nxstage Medical, Inc. | 1 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2003 | K030470 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | FII |
| Aug 24, 1988 | K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 Gambro, Inc. | FII |
| Oct 13, 1987 | K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 Travenol Laboratories, S.A. | FII |
| Sep 9, 1986 | K862716 | HEMOFILTRATION SYSTEM 10 Gambro, Inc. | FII |
| Oct 6, 1982 | K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA Hospal Medical Corp. | FII |
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