Panels › Gastroenterology, Urology › Product code FHS · Class 2
Dialyzer, Single Coil
Regulation 876.5820
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FHS
| Company | 510(k)s | Recalls |
|---|---|---|
| Erika, Inc. | 6 | 0 |
| Gambro, Inc. | 2 | 0 |
| Travenol Laboratories, S.A. | 2 | 0 |
| Bellco Artifidial Organ Spec., Inc. | 1 | 0 |
| Bentley Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 1981 | K812811 | MICROCOIL 80 DIALYZER Erika, Inc. | FHS |
| Sep 16, 1981 | K811974 | MICROCOIL 150 DIALYZER Erika, Inc. | FHS |
| Dec 17, 1980 | K801634 | THE VITA 2 DISPOSABLE DIALYZER Bellco Artifidial Organ Spec., Inc. | FHS |
| May 14, 1980 | K800723 | MICRO-COIL 100 COIL DIALYZER Erika, Inc. | FHS |
| Feb 13, 1980 | K800174 | GAMBRO LUNDIA COIL DIALYZER Gambro, Inc. | FHS |
| Mar 26, 1979 | K790223 | DIALYZER, CD-800 COIL Travenol Laboratories, S.A. | FHS |
| Oct 17, 1978 | K781102 | DIALYZER, DISP., COIL, LUNDIA Gambro, Inc. | FHS |
| Aug 2, 1977 | K771349 | MODIFICATION TO KIDNEY DIALYZER Erika, Inc. | FHS |
| May 10, 1977 | K770735 | DIALYZER, COIL, CD, LSA, 5M1765 Travenol Laboratories, S.A. | FHS |
| Jan 10, 1977 | K761358 | COIL DIALYZER MODEL ALT 140 Bentley Laboratories, Inc. | FHS |
| Nov 19, 1976 | K760702 | ERI-FLO 900 DIALYZER Erika, Inc. | FHS |
| Oct 27, 1976 | K760374 | DIALYZER (MODEL 1850) Erika, Inc. | FHS |
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