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 |
|---|---|---|---|
| Jul 19, 2019 | K182940 | Surdial DX Hemodialysis System Nipro Medical Corporation | KDI |
| May 10, 2018 | K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Feb 23, 2018 | K171671 | Prismaflex System 8.10 Baxter Healthcare Corporation | KDI |
| Dec 13, 2017 | K170790 | SAM CRRT Unit, SAM Cassette CRRT Spectral Medical, Inc., CA | KDI |
| Aug 24, 2017 | K171331 | NxStage System One Nxstage Medical, Inc. | KDI |
| Aug 11, 2017 | K170574 | Diacap Pro Dialyzer B. Braun Avitum AG, DE | KDI |
| May 9, 2017 | K170469 | NxStage System One Plus Nxstage Medical, Inc. | KDI |
| May 3, 2017 | K163530 | PrisMax Control Unit Baxter Healthcare Corp | KDI |
| May 3, 2017 | K162248 | Asahi ViE-U Series Dialyzer Asahi Kasei Medical Co., Ltd., JP | KDI |
| Apr 6, 2017 | K162488 | Optiflux dialyzer Fresenius Medical Care North America | KDI |
| Feb 8, 2017 | K160444 | FB-U Hemodialyzer Nipro Medical Corporation | KDI |
| Nov 18, 2016 | K160558 | RAPIDO HOLLOW-FIBRE DIALYZERS Bellco Srl, IT | KDI |
| Nov 15, 2016 | K160881 | Tablo Console Outset Medical, Inc. | KDI |
| Apr 26, 2016 | K153449 | 2008K2 Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Mar 18, 2016 | K152938 | DBB-06 Hemodialysis Delivery System NIKKISO CO., LTD., JP | KDI |
| Mar 1, 2016 | K143482 | xevonta dialyzer B. Braun Avitum AG, DE | KDI |
| Dec 17, 2015 | K153344 | Asahi REXEED-S Series Dialyzer Asahi Kasei Medical Co., Ltd., JP | KDI |
| Dec 10, 2015 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Oct 29, 2015 | K152367 | Optiflux dialyzer Fresenius Medical Care North America | KDI |
| May 1, 2015 | K150880 | Tablo Console with Wireless Capability Outset Medical | KDI |
| Mar 20, 2015 | K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge Nxstage Medical, Inc. | KDI |
| Sep 10, 2014 | K140866 | TABLO CONSOLE Home Dialysis Plus | KDI |
| Jul 7, 2014 | K133299 | ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY Fresenius Medical Care, North America - Renal Ther | KDI |
| May 19, 2014 | K140526 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Apr 14, 2014 | K140191 | ELISIO-H HEMODIALYZER Nipro Medical Corporation | KDI |
| Mar 3, 2014 | K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW Nxstage Medical, Inc. | KDI |
| Feb 4, 2014 | K132602 | STREAMLINE EXPRESS Nxstage Medical, Inc. | KDI |
| Jan 6, 2014 | K123262 | OPTIFLUX ULTRA DIALYZER Fresenius Medical Care North America | KDI |
| Jan 3, 2014 | K131516 | PRISMAFLEX SYSTEM 7.10 Gambro Renal Products, Inc. | KDI |
| Dec 27, 2013 | K131050 | NXSTAGE 1.6M2 DIALYZER Nxstage Medical, Inc. | KDI |
| Dec 20, 2013 | K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER Nipro Medical Corporation | KDI |
| Dec 19, 2013 | K131381 | ELISIO-H HEMODIALYZER Nipro Medical Corporation | KDI |
| Oct 11, 2013 | K131908 | 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) Fresenius Medical Care Renal Therapies Group, LLC | KDI |
| Jun 26, 2013 | K123288 | HEMOCONCENTRATOR Maquet Cardiopulmonary, AG, DE | KDI |
| May 7, 2013 | K122343 | PUREFLUX-H HEMODIALYZER Nipro Medical Corporation | KDI |
| May 2, 2013 | K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER Gambro Renal Products, Inc. | KDI |
| May 1, 2013 | K122347 | ELISIO-H AND ELISIO-M HEMODIALYZERS Nipro Medical Corporation | KDI |
| Apr 23, 2013 | K122051 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Mar 7, 2013 | K123395 | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Feb 6, 2013 | K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER Asahi Kasei Medical Co., Ltd. | KDI |
| Dec 21, 2012 | K113023 | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER Nxstage Medical, Inc. | KDI |
| Dec 6, 2012 | K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America | KDI |
| Aug 17, 2012 | K121497 | VENOFER PUMP Renal Solutions, Inc. | KDI |
| Apr 27, 2012 | K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER Nephros, Inc. | KDI |
| Mar 6, 2012 | K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente | KDI |
| Feb 2, 2012 | K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America | KDI |
| Dec 21, 2011 | K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America | KDI |
| Oct 21, 2011 | K111639 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care | KDI |
| Jun 17, 2011 | K110823 | PRISMAFLEX Gambro Renal Products, Inc. | KDI |
| May 20, 2011 | K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM Gambro Renal Products, Inc. | KDI |
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