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) |
|---|---|---|---|
| Mar 20, 2018 | Fresenius 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 |
KDI | K153449 |
| Feb 20, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008T, Hemodialysis Delivery System
Product Indicated for acute and chronic dialysis therapy. Terminated |
KDI | K080964 K113427 +3 |
| Feb 15, 2017 | Baxter 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 |
KDI | K110823 |
| Jan 4, 2017 | Baxter 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 |
KDI | K103832 |
| Jan 4, 2017 | Baxter 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 |
KDI | K103832 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K@home Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K2 Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008K Series : Hemodialysis System Terminated |
KDI | K150708 |
| Dec 21, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008T Series Hemodialysis System Terminated |
KDI | K150708 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| May 3, 2016 | B 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 |
KDI | K083460 K963440 |
| Apr 5, 2016 | Fresenius 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 |
KDI | K080964 K113427 +3 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler -High Permeability Hemodialysis System
Model no. NX1000-4 Terminated |
KDI | K140526 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
For home hemodialysis. Terminated |
KDI | K140526 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3.
For home hemodialysis. Terminated |
KDI | K122051 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5-A Terminated |
KDI | K133547 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5 Terminated |
KDI | K133547 |
| Sep 11, 2015 | Medivators, 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 |
KDI | K983085 |
| Sep 4, 2015 | Medtronic Perfusion Systems MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS.
Enables the perfusionist to manage the patient's hematocrit and fluid status. Terminated |
KDI | K923139 K983085 |
| Apr 29, 2015 | Fresenius 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 |
KDI | K994267 |
| Apr 29, 2015 | Fresenius 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 |
KDI | K994267 |
| Apr 29, 2015 | Fresenius 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 |
KDI | K080964 K113427 +3 |
| Apr 29, 2015 | Fresenius 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 |
KDI | K070049 K121421 |
| Mar 13, 2015 | Baxter Healthcare Corp. MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. Completed |
KDI | K895631 |
| Jan 27, 2015 | Fresenius 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 |
KDI | K121341 K121421 +1 |
| Dec 1, 2014 | Gambro 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 |
KDI | None listed |
| Dec 1, 2014 | Gambro 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 |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K042938 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K042938 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K080519 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K041005 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K041005 |
| Aug 13, 2014 | Gambro 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 |
KDI | K011221 |
| Aug 13, 2014 | Gambro 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 |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro 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 |
KDI | K032431 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | K032431 |
| Aug 13, 2014 | Gambro 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 |
KDI | K032431 |
| Jul 17, 2014 | Baxter Healthcare Corp. Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Terminated |
KDI | K895631 |
| Jun 30, 2014 | Baxter Healthcare Corp. Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. Terminated |
KDI | K895631 |
| May 21, 2014 | Gambro 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 |
KDI | K060195 |
| May 21, 2014 | Gambro 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 |
KDI | K072232 |
| May 13, 2014 | Fresenius 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 |
KDI | None listed |
| May 13, 2014 | Fresenius 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 |
KDI | K121341 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K043244 |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux B200 Flux Dialyzers; Product Number: 0500325E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | K082414 |
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