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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2005 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger Terminated |
KDI | K021615 |
| Jun 30, 2005 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | K003425 |
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | K003425 |
| May 3, 2005 | Asahi Medical Co Ltd Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled Terminated |
KDI | K001250 |
| May 3, 2005 | Asahi Medical Co Ltd Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casi Terminated |
KDI | K013418 |
| May 3, 2005 | Asahi Medical Co Ltd Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene bu Terminated |
KDI | K983720 |
| Dec 8, 2004 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Aug 11, 2004 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | K021615 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Terminated |
KDI | K040696 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Terminated |
KDI | K040696 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Terminated |
KDI | K040696 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K030099 |
| Jul 20, 2004 | Asahi Medical Co Ltd Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo Terminated |
KDI | K001250 |
| Dec 4, 2003 | Baxter Healthcare Corp. CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case Terminated |
KDI | None listed |
| Mar 5, 2003 | Baxter Healthcare Corp. Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085
The instrument is part of a high permeability hemodialysis system which c Terminated |
KDI | None listed |
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