Medical Device Manufacturer · US , Waltham , MA

Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...

50 submissions · 50 cleared · Since 2013
50
Total
50
Cleared
0
Denied
48 devices
26-48 of 48
Cleared Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · KDI
Gastroenterology & Urology · 80d
Cleared Sep 21, 2020
Optiflux F180NR Dialyzer
K192707 · KDI
Gastroenterology & Urology · 360d
Cleared Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and...
K201207 · KOC
Gastroenterology & Urology · 136d
Cleared May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
K192209 · KPO
Gastroenterology & Urology · 268d
Cleared Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · KPO
Gastroenterology & Urology · 270d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
K191474 · KPO
Gastroenterology & Urology · 265d
Cleared Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
K190459 · FJI
Gastroenterology & Urology · 178d
Cleared Jan 10, 2019
DIASAFEplusUS
K182367 · FIP
Gastroenterology & Urology · 132d
Cleared May 24, 2018
Fresenius Liberty Select Cycler
K181108 · FKX
Gastroenterology & Urology · 27d
Cleared May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter...
K173593 · KDJ
Gastroenterology & Urology · 181d
Cleared May 10, 2018
2008T BlueStar Hemodialysis Machine
K173972 · KDI
Gastroenterology & Urology · 132d
Cleared May 01, 2018
Liberty Cycler Set
K173718 · FKX
Gastroenterology & Urology · 147d
Cleared Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · KDJ
Gastroenterology & Urology · 78d
Cleared Jan 24, 2018
Cycler Drain Bag Set
K173363 · KDJ
Gastroenterology & Urology · 90d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · KOC
Gastroenterology & Urology · 141d
Cleared Sep 15, 2017
Fresenius Liberty Select Cycler
K171652 · FKX
Gastroenterology & Urology · 102d
Cleared May 18, 2017
bibag
K162716 · KPO
Gastroenterology & Urology · 231d
Cleared Apr 26, 2016
2008K2 Hemodialysis Machine
K153449 · KDI
Gastroenterology & Urology · 148d
Cleared Apr 15, 2016
CRIT-LINE III Blood Chamber II
K160749 · KOC
Gastroenterology & Urology · 28d
Cleared Dec 10, 2015
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T...
K150708 · KDI
Gastroenterology & Urology · 266d
Cleared Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · KOC
Gastroenterology & Urology · 90d
Cleared Jul 30, 2014
LIBERTY PDX CYCLER
K141145 · FKX
Gastroenterology & Urology · 89d
Cleared Oct 11, 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · KDI
Gastroenterology & Urology · 107d
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