Panels › Gastroenterology, Urology › Product code KDI · Class 2
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation 876.5860
7510(k)s in 12 months (346 all time)
11recalls in 12 months (217 all time)
192recalls that name a 510(k)
Top companies in KDI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2011 | K103564 | VENOFER PUMP Renal Solutions, Inc. | KDI |
| Dec 21, 2010 | K101715 | FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 Fresenius Medical Care North America, Design Cente | KDI |
| Oct 23, 2010 | K093069 | NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE Nxstage Medical, Inc. | KDI |
| Jul 9, 2010 | K093964 | VENOFER PUMP Renal Solutions, Inc. | KDI |
| May 27, 2010 | K093902 | MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 Fresenius Medical Care North America | KDI |
| Apr 22, 2010 | K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 B. Braun Avitum AG | KDI |
| Mar 25, 2010 | K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO., LTD., JP | KDI |
| Feb 18, 2010 | K083460 | DIALOG WITH ADIMEA OPTION B. Braun Avitum AG | KDI |
| Feb 17, 2010 | K093120 | XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 Baxter Healthcare Corporation - Renal Division | KDI |
| Feb 9, 2010 | K093379 | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. | KDI |
| Nov 19, 2009 | K090682 | EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 Edwards Lifesciences Services GmbH, GB | KDI |
| Jun 5, 2009 | K083158 | EXALIS, SOFTWARE VERSION 1.15 Gambro, Inc. | KDI |
| Feb 20, 2009 | K083778 | XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 Baxter Healthcare Corporation | KDI |
| Jan 14, 2009 | K080964 | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America | KDI |
| Nov 26, 2008 | K080650 | OMNI-DL SYSTEM Transvivo, Inc. | KDI |
| Nov 19, 2008 | K081313 | SH14 HEMOCONCENTRATOR Sorin Group Italia S.R.L. | KDI |
| Oct 28, 2008 | K082414 | OPTIFLUX F250NR, MODEL 0500325E Fresenius Medical Care North America | KDI |
| Oct 3, 2008 | K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX Asahi Kasei Medical Co., Ltd. | KDI |
| Jun 13, 2008 | K080519 | PRISMAFLEX M150 SET Gambro Renal Products, Inc. | KDI |
| Feb 1, 2008 | K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 Gambro | KDI |
| Nov 2, 2007 | K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 Gambro, Inc. | KDI |
| Sep 28, 2007 | K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO., LTD., JP | KDI |
| Sep 7, 2007 | K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL Gambro Renal Products, Inc. | KDI |
| Sep 7, 2007 | K071854 | AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. | KDI |
| Aug 24, 2007 | K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 Nxstage Medical, Inc. | KDI |
| Aug 17, 2007 | K071518 | DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS B. Braun Medizintechnologie GmbH, DE | KDI |
| Aug 8, 2007 | K071298 | HF JUNIOR HEMOFILTER Minntech Corp. | KDI |
| Jun 7, 2007 | K070320 | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 Edwards Lifesciences Services GmbH, GB | KDI |
| Apr 27, 2007 | K070512 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. | KDI |
| Apr 24, 2007 | K070222 | FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N Fresenius Medical Care North America | KDI |
| Feb 15, 2007 | K063183 | PRISMA M10 PRE SET Gambro Renal Products, Inc. | KDI |
| Dec 13, 2006 | K062922 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. | KDI |
| Oct 19, 2006 | K062079 | XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 Baxter Healthcare Corporation | KDI |
| Oct 18, 2006 | K062090 | PRISMA SYSTEM R03.10A Gambro Renal Products | KDI |
| Jul 31, 2006 | K061837 | NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| May 24, 2006 | K053539 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 Baxter Healthcare Corporation | KDI |
| Apr 24, 2006 | K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE Gambro Renal Products | KDI |
| Feb 2, 2006 | K060008 | AQUADEX FLEXFLOW SYSTEM Chf Solutions, Inc. | KDI |
| Jan 31, 2006 | K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR Minntech Corp. | KDI |
| Dec 9, 2005 | K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H Gambro Renal Products | KDI |
| Nov 9, 2005 | K050609 | AQUADEX SYSTEM Chf Solutions, Inc. | KDI |
| Jun 24, 2005 | K050525 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Jun 13, 2005 | K050727 | MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Jun 9, 2005 | K050603 | OLPUR DIALYZER, MODEL HD 190 Nephros, Inc. | KDI |
| Jun 8, 2005 | K051187 | REXEED SERIES DIALYZERS Asahi Kasei Medical Co., Ltd. | KDI |
| Jan 6, 2005 | K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS Gambro Renal Products | KDI |
| Dec 20, 2004 | K043244 | FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR Fresenius Medical Care North America | KDI |
| Oct 7, 2004 | K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products | KDI |
| Jul 23, 2004 | K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX Asahi Medical Co., Ltd. | KDI |
| Jul 2, 2004 | K041424 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
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