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 |
|---|---|---|---|
| May 26, 2004 | K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| May 24, 2004 | K040255 | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE Gambro Renal Products, Inc. | KDI |
| Apr 27, 2004 | K040489 | AQUADEX SYSTEM 100, MODEL A1100 Chf Solutions, Inc. | KDI |
| Jan 30, 2004 | K034064 | FRESENIUS ULTRAFLO HPX HEMODIALYZER Fresenius Medical Care North America | KDI |
| Nov 20, 2003 | K023874 | SYSTEM 100 ULTRAFILTRATION CATHETER Chf Solutions, Inc. | KDI |
| Oct 30, 2003 | K023509 | DBB-05 HEMODIALYSIS DELIVERY SYSTEM Davita Clinical Research (Trri) | KDI |
| Oct 28, 2003 | K032356 | NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Sep 29, 2003 | K030050 | TORAYSULFONE DIALYZER, BS-L SERIES Toray Industries (America), Inc. | KDI |
| Sep 15, 2003 | K032431 | PRISMA M60/M100 SETS Gambro, Inc. | KDI |
| Jun 17, 2003 | K030099 | BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 Baxter Healthcare Corp | KDI |
| May 30, 2003 | K031378 | FRESENIUS ULTRAFLUX HEMODIALYZER Fresenius Medical Care North America | KDI |
| May 23, 2003 | K030592 | GAMBRO POLYFLUX, MODEL 140H, 170H, 210H Gambro Renal Care Products | KDI |
| Apr 25, 2003 | K030975 | EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 Baxter Healthcare Corp | KDI |
| Apr 25, 2003 | K030974 | EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 Baxter Healthcare Corp | KDI |
| Mar 14, 2003 | K024124 | SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT Chf Solutions, Inc. | KDI |
| Feb 21, 2003 | K023664 | SYNTRA + DIALYZER, MODEL 200 Baxter Healthcare Corp | KDI |
| Dec 12, 2002 | K013562 | AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE Baxter Healthcare Corp | KDI |
| Dec 11, 2002 | K014152 | NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Nov 18, 2002 | K021615 | BAXTER ACCURA SYSTEM, MODEL 5M5660 Baxter Healthcare Corp | KDI |
| Nov 4, 2002 | K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT Dideco S.P.A. | KDI |
| Oct 25, 2002 | K023224 | INFUSION CATHETER EXTENSION SET Chf Solutions, Inc. | KDI |
| Aug 6, 2002 | K010805 | PRISMA SYSTEM Gambro Renal Products | KDI |
| Jul 9, 2002 | K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY Asahi Medical Co., Ltd. | KDI |
| Jun 3, 2002 | K013733 | SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET Chf Solutions, Inc. | KDI |
| Apr 17, 2002 | K020858 | NXSTAGE THERAPY SYSTEM Nxstage Medical, Inc. | KDI |
| Mar 26, 2002 | K010131 | PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB Aksys, Ltd. | KDI |
| Mar 4, 2002 | K011269 | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR Nxstage Medical, Inc. | KDI |
| Jan 7, 2002 | K011537 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS Dynamic Technology Corp., TW | KDI |
| Nov 20, 2001 | K013550 | CLIRANS E-SERIES DIALYZER Terumo Medical Corp. | KDI |
| Oct 31, 2001 | K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET Gambro Renal Products | KDI |
| Oct 19, 2001 | K012510 | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM Nxstage Medical, Inc. | KDI |
| Oct 15, 2001 | K002512 | TORAYSULFONE DIALYZER Toray Industries (America), Inc. | KDI |
| Oct 10, 2001 | K010985 | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L Gambro Renal Products | KDI |
| Jun 4, 2001 | K010667 | GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R Gambro Renal Products | KDI |
| Apr 30, 2001 | K003023 | COBE HC 700 MIDI HEMOCONCENTRATOR Hospal Industrie | KDI |
| Mar 22, 2001 | K000724 | MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 Medica S.R.L. | KDI |
| Feb 14, 2001 | K002210 | SYNTRA DIALYZER, MODEL SYNTRA 120, 160 Baxter Healthcare Corp | KDI |
| Feb 1, 2001 | K003425 | CLIRANS E-SERIES HOLLOW FIBER DIALYZERS Terumo Medical Corp. | KDI |
| Jan 17, 2001 | K001283 | LIFEMATE HEMOFILTRATION SYSTEM Nxstage Medical, Inc. | KDI |
| Jan 4, 2001 | K003498 | FRESENIUS OPTIFLUX 200A Fresenius Medical Care North America | KDI |
| Aug 25, 2000 | K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L Toray Industries (America), Inc. | KDI |
| Aug 25, 2000 | K002277 | FRESENIUS OPTIFLUX 200NR Fresenius Medical Care North America | KDI |
| Aug 16, 2000 | K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) Asahi Medical Co., Ltd. | KDI |
| Jul 7, 2000 | K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET Gambro Renal Products | KDI |
| Jun 2, 2000 | K001422 | PSN HEMODIALYZER, MODELS PSN 170, PSN 210 Baxter Healthcare Corp | KDI |
| Apr 4, 2000 | K000028 | RENAFLO II HF 2000 HEMOFILTER Minntech Corp. | KDI |
| Mar 16, 2000 | K994267 | FRESENIUS 2008K Fresenius Medical Care | KDI |
| Jan 18, 2000 | K992573 | AF-220 HEMODIALYZER Althin Medical AB, SE | KDI |
| Jan 18, 2000 | K992566 | AF-150 HEMODIALYZER Althin Medical AB, SE | KDI |
| Jan 18, 2000 | K992564 | AF-180 HEMODIALYZER Althin Medical AB, SE | KDI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.