Panels › Gastroenterology, Urology › Product code FIP · Class 2
Subsystem, Water Purification
Regulation 876.5665
1510(k)s in 12 months (117 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in FIP
| Company | 510(k)s | Recalls |
|---|---|---|
| AmeriWater, LLC | 10 | 2 |
| Fresenius Medical Care Holdings, Inc. | 0 | 8 |
| Mar Cor Purification, Inc. | 4 | 3 |
| Better Water, Inc. | 4 | 0 |
| Fresenius Medical Care Renal Therapies Group, LLC | 4 | 0 |
| Dayton Water Systems | 3 | 0 |
| Gambro Renal Products | 3 | 0 |
| Minntech Corp. | 3 | 0 |
| Nephros, Inc. | 3 | 0 |
| Usfilter/Ionpure, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 1995 | K945136 | RENAGUARD DIALYSATE FILTER Minntech Corp. | FIP |
| Dec 29, 1994 | K931595 | REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION Osmonics, Inc. | FIP |
| Sep 29, 1994 | K934848 | MASTER ALERT Master Hydro Systems, Inc. | FIP |
| Jul 2, 1993 | K915258 | SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM Aqua-Med Systems, Inc. | FIP |
| Mar 13, 1990 | K894300 | SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS U.S. Filter/Continental Water Systems | FIP |
| Nov 8, 1989 | K894106 | DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST Cd Medical, Inc. | FIP |
| Mar 16, 1988 | K871242 | REVERSE OSMOSIS WATER PURIFICATION SYSTEM Medro Systems, Inc. | FIP |
| Oct 23, 1987 | K873487 | HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES Water Pure, Inc. | FIP |
| Oct 29, 1986 | K863720 | HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES Water Pure, Inc. | FIP |
| Aug 2, 1984 | K842215 | ASCORBIC ACID Organon Teknika Corp. | FIP |
| Jul 6, 1984 | K841403 | HEMO-RO WATER PURIFICATION SYS Millipore Corp. | FIP |
| Oct 13, 1982 | K822385 | EXTRAPURE REVERSE OSMOSIS WATER UNIT Extracorporeal Medical Specialities, Inc. | FIP |
| Jul 10, 1981 | K811678 | GAMBRO WATER PURIFICATION MONITOR WRD Gambro, Inc. | FIP |
| Dec 15, 1980 | K802474 | CMR 300, ROWATER TREATMENT UNIT U-Marc, Inc. | FIP |
| Apr 8, 1980 | K800305 | WATER CONDUCTIVITY MONITOR & CONTROLLER Darco Water Systems, Inc. | FIP |
| Jul 3, 1979 | K791086 | CENTRY 2 SYSTEM #016, 103, 016, 104 Cobe Laboratories, Inc. | FIP |
| Oct 4, 1977 | K771763 | HEMO-RO Millipore Corp. | FIP |
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