Panels › Gastroenterology, Urology › Product code FJG · Class 2
Dialyzer, Parallel Flow
Regulation 876.5820
0510(k)s in 12 months (36 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FJG
| Company | 510(k)s | Recalls |
|---|---|---|
| Gambro, Inc. | 7 | 0 |
| Cobe Laboratories, Inc. | 4 | 0 |
| Extracorporeal Medical Specialities, Inc. | 4 | 0 |
| Hospal Medical Corp. | 4 | 0 |
| Cyberex Corp. | 3 | 0 |
| Medical, Inc. | 3 | 0 |
| Cobe Renal Care, Inc. | 2 | 0 |
| Travenol Laboratories, S.A. | 2 | 0 |
| Akcess Medical Products, Inc. | 1 | 0 |
| Bellco Artifidial Organ Spec., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 1994 | K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS Cobe Renal Care, Inc. | FJG |
| Aug 26, 1994 | K933680 | GAMBRO LUNDIA PRO 200 DIALYZER Cobe Renal Care, Inc. | FJG |
| Sep 21, 1992 | K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 National Medical Care, Medical Products Div., Inc. | FJG |
| Mar 6, 1992 | K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS C.G.H. Medical, Inc. | FJG |
| Aug 2, 1990 | K901368 | HEMOSPAL KITS A1, A2D, AO, & A1D Gambro-Hospal, Inc. | FJG |
| Aug 1, 1990 | K902203 | TENCKHOFF PERITONEAL DIALYSIS KIT Akcess Medical Products, Inc. | FJG |
| Sep 29, 1986 | K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N Gambro, Inc. | FJG |
| Jan 8, 1986 | K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER Gambro, Inc. | FJG |
| Mar 31, 1982 | K820694 | COBE PPD 1.3L, #18-520-009 Cobe Laboratories, Inc. | FJG |
| Aug 31, 1981 | K812336 | COBE PPD 1.9 Cobe Laboratories, Inc. | FJG |
| Jun 12, 1981 | K811440 | EXP 600 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
| Jun 12, 1981 | K811439 | EXP 200 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
| Jun 9, 1981 | K810066 | COBE PPD .8 Cobe Laboratories, Inc. | FJG |
| May 5, 1981 | K810837 | CYBER 80 HEMODIALYZER Cyberex Corp. | FJG |
| Mar 20, 1981 | K802478 | CYBER 120 HEMODIALYZER Cyberex Corp. | FJG |
| Mar 4, 1981 | K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER NIKKISO CO., LTD. | FJG |
| Jan 29, 1981 | K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE Extracorporeal Medical Specialities, Inc. | FJG |
| Dec 22, 1980 | K802389 | GAMBRO LUNDIA PLATE DISP. DIALYZER Gambro, Inc. | FJG |
| Dec 18, 1980 | K801633 | THE BRAVO NEW PARALLEL FLOW DIALYZER Bellco Artifidial Organ Spec., Inc. | FJG |
| Sep 26, 1980 | K801451 | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM Medical, Inc. | FJG |
| Aug 27, 1980 | K801377 | CYBER 120 HEMODIALYZER Cyberex Corp. | FJG |
| Apr 10, 1980 | K800424 | LUNDIA PLATE DISP. Gambro, Inc. | FJG |
| Feb 6, 1980 | K792611 | GAMBRO LUNDIA PLATE DIALYZER Gambro, Inc. | FJG |
| Nov 13, 1979 | K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER Extracorporeal Medical Specialities, Inc. | FJG |
| Aug 7, 1979 | K791448 | HEMODIALYZERS RP-510 AND RP-514 Hospal Medical Corp. | FJG |
| May 8, 1979 | K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER Medical, Inc. | FJG |
| May 2, 1979 | K790533 | HD CAPILLARY FILM DIALYZER, MODEL 1001 Travenol Laboratories, S.A. | FJG |
| Mar 6, 1979 | K790001 | DIALYZER, MODEL F.M.D 150 Hospal Medical Corp. | FJG |
| Feb 21, 1979 | K781966 | DIALYZER, MAGNIFLO 100 PARALLEL PLATE Erika, Inc. | FJG |
| Dec 15, 1978 | K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE Medical, Inc. | FJG |
| Jul 17, 1978 | K780700 | LUNDIA PLATE DISPOSABLE DIALYZER Gambro, Inc. | FJG |
| May 19, 1978 | K780427 | RP-510/RP-514 PARALLEL PLATE DIALYZERS Hospal Medical Corp. | FJG |
| Jan 26, 1978 | K772318 | DIALYZER STANDARD, CODE 5DM1780 Travenol Laboratories, S.A. | FJG |
| Sep 15, 1977 | K771354 | PARALLEL PLATE DIALYZERS Hospal Medical Corp. | FJG |
| Jun 14, 1977 | K770858 | DIALYZER, ULTRADIFFUSER, DISPOSABLE Gambro, Inc. | FJG |
| Apr 15, 1977 | K770578 | PARALLEL PLATE DIALYZER Cobe Laboratories, Inc. | FJG |
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