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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)
Oct 12, 2022Baxter Healthcare Corporation
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Open, Classified
KDIK042938
Oct 12, 2022Baxter Healthcare Corporation
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
Open, Classified
KDIK212216
Oct 12, 2022Baxter Healthcare Corporation
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
Open, Classified
KDIK042938
Oct 12, 2022Baxter Healthcare Corporation
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Open, Classified
KDIK080519
Oct 12, 2022Baxter Healthcare Corporation
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Open, Classified
KDIK041005
May 4, 2022Fresenius Medical Care Holdings, Inc.
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Terminated
KDIK162488
Mar 15, 2022Baxter Healthcare Corporation
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Open, Classified
KDINone listed
Mar 15, 2022Baxter Healthcare Corporation
PrisMax System, Product Code 955724
Open, Classified
KDINone listed
Mar 15, 2022Baxter Healthcare Corporation
PrisMax System, Product Code 955626
Open, Classified
KDINone listed
Jan 28, 2022B Braun Medical Inc
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts fo
Terminated
KDIK083460
Jan 28, 2022B Braun Medical Inc
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts fo
Terminated
KDIK083460
Jan 20, 2022Outset Medical, Inc.
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Open, Classified
KDIK190793
K200741
Nov 24, 2021Nikkiso Ltd - Shizuoka Plant
DBB-06 Hemodialysis Delivery System
Open, Classified
KDIK091978
K152938
Sep 29, 2021Baxter Healthcare Corporation
Hemodialysis Delivery System, Software Version 2.x.
Open, Classified
KDIK190910
Jul 22, 2021Baxter Healthcare Corporation
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Terminated
KDIK042938
Jul 22, 2021Baxter Healthcare Corporation
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 S
Terminated
KDIK041005
Jan 28, 2021Baxter Healthcare Corporation
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Terminated
KDINone listed
Jan 28, 2021Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Terminated
KDIK131516
Jan 28, 2021Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Terminated
KDIK110823
Jan 28, 2021Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Terminated
KDIK072093
Jan 7, 2021Baxter Healthcare Corporation
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maint
Terminated
KDIK190910
Apr 7, 2020Baxter Healthcare Corporation
Prismaflex Control Unit
Terminated
KDIK131516
Mar 12, 2020Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2
Open, Classified
KDIK173972
Mar 12, 2020Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 19
Open, Classified
KDIK173972
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Feb 6, 2020Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Terminated
KDIK072093
K110823
Jan 29, 2020Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery E
Terminated
KDIK153449
K173972
Nov 15, 2019Baxter Healthcare Corporation
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Terminated
KDIK130039
Oct 30, 2019Baxter Healthcare Corporation
TherMax Blood Warmer Unit
Terminated
KDIK190910
Oct 4, 2019Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Open, Classified
KDIK072093
Oct 4, 2019Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Open, Classified
KDIK072093
Oct 4, 2019Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Open, Classified
KDIK072093
Oct 4, 2019Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Open, Classified
KDIK072093
Oct 4, 2019Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Open, Classified
KDIK072093
May 31, 2019Baxter Healthcare Corporation
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Terminated
KDIK130039
May 31, 2019Baxter Healthcare Corporation
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Terminated
KDIK130039
Apr 3, 2019Fresenius Medical Care Renal Therapies Group, LLC
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare fa
Terminated
KDIK173972
Nov 5, 2018Fresenius Medical Care Renal Therapies Group, LLC
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Terminated
KDIK152367
K162488
Jul 13, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Terminated
KDIK173972
Jul 13, 2018Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Terminated
KDIK173972
Jun 11, 2018NxStage Medical, Inc.
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prio
Terminated
KDIK071263
Apr 24, 2018Baxter Healthcare Corporation
Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute
Terminated
KDIK131516
Apr 24, 2018Baxter Healthcare Corporation
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute
Terminated
KDIK131516
Apr 24, 2018Baxter Healthcare Corporation
Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acut
Terminated
KDINone listed
Apr 24, 2018Baxter Healthcare Corporation
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute
Terminated
KDIK110823
Apr 24, 2018Baxter Healthcare Corporation
Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute
Terminated
KDIK072093

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