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) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200A High Flux Dialyzers; Product Number: 0500320A.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K003498 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K002277 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K002761 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K002277 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K002277 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K002761 |
| Feb 3, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine
Part Number: 650103.
The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. Terminated |
KDI | None listed |
| Jan 6, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius 2008 Series Hemodialysis Machines:
Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T
The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indica Terminated |
KDI | K070049 K093902 +2 |
| Aug 26, 2013 | Fresenius Medical Care Holdings, Inc. dba Renal Solutions 2008 MeDS Pump, Venofer(R) Pump
Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat Terminated |
KDI | K121497 |
| Jul 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Service Replacement 0-Ring.
Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T Terminated |
KDI | K080964 K093902 +4 |
| Jun 21, 2013 | Baxter Healthcare Corp. Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Intended to isolate the Easy-Lock connector of the solution transfer set. Terminated |
KDI | K895631 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | K082515 |
| Mar 30, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F160NRe Hemodialyzer
Catalog number: 0500316E
Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Terminated |
KDI | K003498 |
| Jan 20, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis
Catalog No. 0500325E
The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with a Terminated |
KDI | K082414 |
| Nov 7, 2011 | Baxter Healthcare Renal Div Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P.
Hemodialysis and Continuous Renal Rep Terminated |
KDI | K970446 |
| Apr 6, 2011 | Gambro Renal Products, Incorporated Prismaflex System, Catalog Number 107493,
Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Terminated |
KDI | K072093 |
| Mar 22, 2011 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone.
Intended for use as an artificial kidney system to the treatment of patients with renal Terminated |
KDI | K082414 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KDI | K994267 |
| Jul 1, 2010 | Fresenius Medical Care North America Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404.
Designed for single use acute and chronic hemodialysis. Terminated |
KDI | K002277 |
| Jan 27, 2010 | Edwards Lifesciences, Llc Edwards Lifesciences Aquarius System Model GEF09800. Terminated |
KDI | K070320 |
| Nov 12, 2009 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
The Hemodialysis and Continuous Renal Terminated |
KDI | K013562 K954987 |
| Mar 25, 2008 | Gambro Renal Products, Inc. Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 Terminated |
KDI | K001156 |
| Feb 1, 2008 | Fresenius Medical Care North America Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) Terminated |
KDI | K002277 |
| Sep 20, 2007 | NxStage Medical, Inc. NxStage Cartridge Express, CAR-170, for hemodialysis. Terminated |
KDI | K050525 K061837 |
| Mar 31, 2007 | Gambro Renal Products, Inc. Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. Terminated |
KDI | K041005 |
| Nov 21, 2006 | Gambro Renal Products, Inc. Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy. Terminated |
KDI | K001156 |
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone/PVP housed within a plastic casing of styrene copolymer, Terminated |
KDI | K051187 |
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block po Terminated |
KDI | K041726 |
| Nov 14, 2006 | Baxter Healthcare Renal Div Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Oct 12, 2006 | Gambro Renal Products, Inc. Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy. Terminated |
KDI | K041005 |
| Jul 25, 2006 | Baxter Healthcare Renal Div Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare C Terminated |
KDI | K030099 K103562 +2 |
| Jul 13, 2006 | Aksys, Ltd. Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Manufactured in the USA for Aksys Lt Terminated |
KDI | K010131 |
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma HF1000 preset, Part No. 8399050. Terminated |
KDI | K011221 |
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma M100 preset, Part No. 8353486. Terminated |
KDI | K032431 K980386 +1 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3051, 5M3051R Terminated |
KDI | K970591 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with Terminated |
KDI | K974652 |
| Jan 6, 2006 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
KDI | K013562 K030099 +1 |
| Dec 31, 2005 | Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux
Catalog Number: 0500318N Terminated |
KDI | None listed |
| Dec 31, 2005 | Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux
Catalog Number: 0500316N Terminated |
KDI | K002277 |
| Dec 14, 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 |
| Nov 16, 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 |
| Oct 1, 2005 | Gambro Renal Products Prisma continuous renal replacement system. Terminated |
KDI | K010805 K993064 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | K030099 |
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