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 |
|---|---|---|---|
| Oct 7, 2004 | K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES Isopure, Corp. | FIP |
| Aug 9, 2004 | K033648 | PERFORMANCE WATER TREATMENT SYSTEM Performance Water Systems, LLC | FIP |
| Oct 21, 2003 | K030348 | BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE Biolab Equipment Canada , Ltd., CA | FIP |
| Oct 2, 2003 | K032004 | AQUABOSS ECORO DIA 50 Lauer Ltd., Hong Kong, DE | FIP |
| Sep 3, 2003 | K030652 | MEDRO SPD Usfilter/Ionpure, Inc. | FIP |
| Aug 14, 2003 | K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS Ameriwater | FIP |
| May 28, 2003 | K022448 | WATER PURIFICATION SYSTEM Purity Water Company of San Antonio, Inc. | FIP |
| Apr 7, 2003 | K030059 | PORTABLE RO+ MODEL MROS09 Ameriwater | FIP |
| Feb 11, 2003 | K022747 | HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM Hydropure Systems, Inc. | FIP |
| Nov 1, 2002 | K011005 | PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS Pure Water Solutions, Inc. | FIP |
| Aug 5, 2002 | K001755 | MPW HEMODIALYSIS WATER PURIFICATION SYSTEM Mpw Industrial Water Services, Inc. | FIP |
| Aug 1, 2002 | K021352 | DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS Dayton Water Systems | FIP |
| Mar 8, 2002 | K013677 | MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM Usfilter/Ionpure, Inc. | FIP |
| Feb 6, 2002 | K014169 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS Bob J. Johnson & Assoc., Inc. | FIP |
| Nov 1, 2001 | K003957 | DIACLEAR ULTRAFILTER Gambro Renal Products | FIP |
| Sep 28, 2001 | K010592 | AQUA WATER TREATMENT FOR HEMODIALYSIS Aqua Water Treatment, Inc. | FIP |
| Jun 22, 2001 | K003877 | MAR COR SERVICES SEMPER PURE RO MACHINE Mar Cor Services, Inc. | FIP |
| Feb 16, 2001 | K002045 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Total Water Treatment Systems, Inc. | FIP |
| Jan 2, 2001 | K994292 | WATER PURIFICATION SYSTEM Water & Power Technologies, Inc. | FIP |
| Dec 22, 2000 | K994279 | PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) Pure Water Solutions, Inc. | FIP |
| Dec 15, 2000 | K001282 | AIW WATER SYSTEM FOR HEMODIALYSIS American Industrial Water | FIP |
| Dec 11, 2000 | K000249 | SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 Schaefer Water Centers | FIP |
| Oct 25, 2000 | K001811 | NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM Neu-Ion, Inc. | FIP |
| Aug 28, 2000 | K991495 | FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS Fluid Process Systems, Inc. | FIP |
| Aug 14, 2000 | K993806 | DIALGUARD ENDOTOXIN REMOVAL DEVICE Clarigen, Inc. | FIP |
| May 25, 2000 | K993877 | NELSON WATER SYSTEMS FOR HEMODIALYSIS Nelson Environmental Technologies, Inc. | FIP |
| May 3, 2000 | K993520 | H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Serv-A-Pure Co. | FIP |
| Apr 14, 2000 | K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS Ameriwater | FIP |
| Jan 24, 2000 | K993200 | MD 420/440/460/470/480/490 Isopure, Corp. | FIP |
| Jan 24, 2000 | K992786 | PURE WATER, INC.'S WATER PURIFICATION SYSTEMS Pure Water, Inc. | FIP |
| Jan 14, 2000 | K991916 | VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Virginia Water Systems, Inc. | FIP |
| Nov 18, 1999 | K983239 | WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS Rasco | FIP |
| Apr 28, 1999 | K983512 | WATER TREATMENT SYSTEM FOR HEMODIALYSIS Water Vault, Inc. | FIP |
| Mar 8, 1999 | K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS Minntech Corp. | FIP |
| Dec 31, 1998 | K981680 | ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS Dayton Water Systems | FIP |
| Nov 16, 1998 | K980182 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Usfilter/Ionpure, Inc. | FIP |
| Sep 23, 1998 | K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H Gambro Healthcare | FIP |
| May 18, 1998 | K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM Gambro Healthcare | FIP |
| Dec 19, 1997 | K974127 | HYDRA METER Automata Instrumentation, Inc. | FIP |
| Nov 26, 1997 | K964539 | PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST Zyzatech Water Systems, Inc. | FIP |
| May 28, 1996 | K945559 | MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS Mar Cor Services, Inc. | FIP |
| Feb 20, 1996 | K944493 | REVERSE OSMOSIS SYSTEM G.E.M. Water Systems | FIP |
| Jan 24, 1996 | K954928 | PORTABLE REVERSE OSMOSIS MACHINE Better Water, Inc. | FIP |
| Dec 15, 1995 | K954349 | FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS Minntech Corp. | FIP |
| Dec 15, 1995 | K945066 | AWESMOSIS Applied Water Engineering, Inc. | FIP |
| Nov 29, 1995 | K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER Fresenius USA, Inc. | FIP |
| Aug 24, 1995 | K924695 | ASEPTECH PORTABLE RO+ SYSTEM Dayton Water Systems | FIP |
| Aug 9, 1995 | K952215 | SERIM HISENSE TEST KIT Serim Research Corp. | FIP |
| Jun 13, 1995 | K920186 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Better Water, Inc. | FIP |
| Apr 28, 1995 | K944385 | MD400 A/B/C/D/E/F/G International Purification Systems, Inc. | FIP |
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