ClearanceBrief
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)
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Top companies in KDI

DateFirm and productCodeLinked 510(k)
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK003498
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK002277
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK002761
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK002277
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Terminated
KDINone listed
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK002277
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK002761
Feb 3, 2014Fresenius 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
KDINone listed
Jan 6, 2014Fresenius 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
KDIK070049
K093902 +2
Aug 26, 2013Fresenius 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
KDIK121497
Jul 11, 2013Fresenius 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
KDIK080964
K093902 +4
Jun 21, 2013Baxter 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
KDIK895631
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Sep 20, 2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Terminated
KDIK082515
Mar 30, 2012Fresenius 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
KDIK003498
Jan 20, 2012Fresenius 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
KDIK082414
Nov 7, 2011Baxter 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
KDIK970446
Apr 6, 2011Gambro 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
KDIK072093
Mar 22, 2011Fresenius 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
KDIK082414
Aug 15, 2010Fresenius Medical Care North America
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Terminated
KDIK994267
Jul 1, 2010Fresenius 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
KDIK002277
Jan 27, 2010Edwards Lifesciences, Llc
Edwards Lifesciences Aquarius System Model GEF09800.
Terminated
KDIK070320
Nov 12, 2009Baxter 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
KDIK013562
K954987
Mar 25, 2008Gambro 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
KDIK001156
Feb 1, 2008Fresenius Medical Care North America
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Terminated
KDIK002277
Sep 20, 2007NxStage Medical, Inc.
NxStage Cartridge Express, CAR-170, for hemodialysis.
Terminated
KDIK050525
K061837
Mar 31, 2007Gambro Renal Products, Inc.
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Terminated
KDIK041005
Nov 21, 2006Gambro Renal Products, Inc.
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
Terminated
KDIK001156
Nov 14, 2006Asahi 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
KDIK051187
Nov 14, 2006Asahi 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
KDIK041726
Nov 14, 2006Baxter Healthcare Renal Div
Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Terminated
KDIK992894
Oct 12, 2006Gambro Renal Products, Inc.
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Terminated
KDIK041005
Jul 25, 2006Baxter 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
KDIK030099
K103562 +2
Jul 13, 2006Aksys, 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
KDIK010131
Apr 5, 2006Gambro Renal Products, Inc.
Gambro Prisma HF1000 preset, Part No. 8399050.
Terminated
KDIK011221
Apr 5, 2006Gambro Renal Products, Inc.
Gambro Prisma M100 preset, Part No. 8353486.
Terminated
KDIK032431
K980386 +1
Mar 29, 2006Baxter Healthcare Renal Div
Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3051, 5M3051R
Terminated
KDIK970591
Mar 29, 2006Baxter 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
KDIK974652
Jan 6, 2006Baxter 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
KDIK013562
K030099 +1
Dec 31, 2005Fresenius Medical Care North America
Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
Terminated
KDINone listed
Dec 31, 2005Fresenius Medical Care North America
Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
Terminated
KDIK002277
Dec 14, 2005Baxter 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
KDIK992894
Nov 16, 2005Baxter 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
KDIK021615
Oct 1, 2005Gambro Renal Products
Prisma continuous renal replacement system.
Terminated
KDIK010805
K993064
Aug 24, 2005Baxter Healthcare Renal Div
Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
Terminated
KDIK030099

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