Panels › Gastroenterology, Urology › Product code FLD · Class 2
Apparatus, Hemoperfusion, Sorbent
Regulation 876.5870
0510(k)s in 12 months (11 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in FLD
| Company | 510(k)s | Recalls |
|---|---|---|
| Gambro Renal Products | 3 | 2 |
| Clark Research and Development Inc | 0 | 4 |
| Hemocleanse, Inc. | 3 | 0 |
| Extracorporeal Medical Specialities, Inc. | 2 | 0 |
| American Health Care Systems, Inc. | 1 | 0 |
| Asahi Medical Co., Ltd. | 1 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Gambro, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2014 | K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT Gambro Renal Products, Inc. | FLD |
| Dec 14, 2012 | K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) Gambro Renal Products, Inc. | FLD |
| May 27, 2005 | K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) Gambro Renal Products | FLD |
| Sep 10, 1999 | K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) Hemocleanse, Inc. | FLD |
| Aug 13, 1999 | K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK Hemocleanse, Inc. | FLD |
| Oct 22, 1997 | K971015 | AHCS HEMOPERFUSION SYSTEM American Health Care Systems, Inc. | FLD |
| Feb 15, 1996 | K953751 | BIOLOGIC-DT SYSTEM Hemocleanse, Inc. | FLD |
| Mar 17, 1989 | K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 Asahi Medical Co., Ltd. | FLD |
| Dec 29, 1987 | K873643 | GAMBRO ADSORBA 150C Gambro, Inc. | FLD |
| May 30, 1984 | K840532 | HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. | FLD |
| Aug 26, 1983 | K831029 | HEMOPERFUSION SYSTEM TP-400 Extracorporeal Medical Specialities, Inc. | FLD |
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