Panels › Gastroenterology, Urology › Product code FIL · Class 2
System, Dialysate Delivery, Single Pass
Regulation 876.5820
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FIL
| Company | 510(k)s | Recalls |
|---|---|---|
| Travenol Laboratories, S.A. | 2 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Cyberex Corp. | 1 | 0 |
| Extracorporeal Medical Specialities, Inc. | 1 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| Gambro, Inc. | 1 | 0 |
| Hemametrics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2002 | K011741 | CRIT-LINE MONITOR III TQA (CLM TQA) Hemametrics | FIL |
| Apr 19, 1990 | K901038 | SPS 550-IPS (INTEGRATED PATIENT STATION) Baxter Healthcare Corp | FIL |
| May 11, 1989 | K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM Fresenius USA, Inc. | FIL |
| Jun 27, 1979 | K790824 | REPGREEN ULTRAFILTRATION MONITOR Cyberex Corp. | FIL |
| Dec 7, 1978 | K781633 | ULTRAFILTRATION SCALE Extracorporeal Medical Specialities, Inc. | FIL |
| Nov 30, 1977 | K771875 | ULTRAFILTRATION MONITOR 5M9034 Travenol Laboratories, S.A. | FIL |
| Aug 2, 1977 | K771227 | AK-10 Gambro, Inc. | FIL |
| Feb 1, 1977 | K770137 | NEGATIVE PRESSURE ADAPTER 5M1350 Travenol Laboratories, S.A. | FIL |
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