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)
Mar 20, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861
Terminated
KDIK153449
Feb 20, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Terminated
KDIK080964
K113427 +3
Feb 15, 2017Baxter Healthcare Corporation
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal
Terminated
KDIK110823
Jan 4, 2017Baxter Healthcare Corporation
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighin
Terminated
KDIK103832
Jan 4, 2017Baxter Healthcare Corporation
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighin
Terminated
KDIK103832
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K@home Series : Hemodialysis System
Terminated
KDIK150708
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K2 Series : Hemodialysis System
Terminated
KDIK150708
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008K Series : Hemodialysis System
Terminated
KDIK150708
Dec 21, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008T Series Hemodialysis System
Terminated
KDIK150708
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure
Terminated
KDIK083460
K963440
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failu
Terminated
KDIK083460
K963440
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments
Terminated
KDIK083460
K963440
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for
Terminated
KDIK083460
K963440
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patie
Terminated
KDIK083460
K963440
May 3, 2016B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with a
Terminated
KDIK083460
K963440
Apr 5, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with b
Terminated
KDIK080964
K113427 +3
Oct 29, 2015NxStage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Terminated
KDIK140526
Oct 29, 2015NxStage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Terminated
KDIK140526
Oct 29, 2015NxStage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Terminated
KDIK122051
Oct 29, 2015NxStage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Terminated
KDIK133547
Oct 29, 2015NxStage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Terminated
KDIK133547
Sep 11, 2015Medivators, Inc.
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during an
Terminated
KDIK983085
Sep 4, 2015Medtronic Perfusion Systems
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Terminated
KDIK923139
K983085
Apr 29, 2015Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HE
Terminated
KDIK994267
Apr 29, 2015Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and D
Terminated
KDIK994267
Apr 29, 2015Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K
Terminated
KDIK080964
K113427 +3
Apr 29, 2015Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYST
Terminated
KDIK070049
K121421
Mar 13, 2015Baxter Healthcare Corp.
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Completed
KDIK895631
Jan 27, 2015Fresenius Medical Care Holdings, Inc.
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home
Terminated
KDIK121341
K121421 +1
Dec 1, 2014Gambro Renal Products Inc
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure
Terminated
KDINone listed
Dec 1, 2014Gambro Renal Products Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by h
Terminated
KDINone listed
Aug 13, 2014Gambro Renal Products, Incorporated
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK042938
Aug 13, 2014Gambro Renal Products, Incorporated
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK042938
Aug 13, 2014Gambro Renal Products, Incorporated
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK080519
Aug 13, 2014Gambro Renal Products, Incorporated
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK041005
Aug 13, 2014Gambro Renal Products, Incorporated
Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK041005
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK011221
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK032431
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK032431
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK032431
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK032431
Aug 13, 2014Gambro Renal Products, Incorporated
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Terminated
KDIK032431
Jul 17, 2014Baxter Healthcare Corp.
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Terminated
KDIK895631
Jun 30, 2014Baxter Healthcare Corp.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Terminated
KDIK895631
May 21, 2014Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Terminated
KDIK060195
May 21, 2014Gambro Renal Products, Incorporated
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Terminated
KDIK072232
May 13, 2014Fresenius Medical Care Holdings, Inc.
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Terminated
KDINone listed
May 13, 2014Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 20
Terminated
KDIK121341
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK043244
Feb 26, 2014Fresenius Medical Care Holdings, Inc.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Terminated
KDIK082414

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