Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...
50
Total
50
Cleared
0
Denied
48 devices
Cleared
Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
Gastroenterology & Urology
80d
Cleared
Sep 21, 2020
Optiflux F180NR Dialyzer
Gastroenterology & Urology
360d
Cleared
Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and...
Gastroenterology & Urology
136d
Cleared
May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
Gastroenterology & Urology
268d
Cleared
Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
Gastroenterology & Urology
270d
Cleared
Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
Gastroenterology & Urology
265d
Cleared
Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
Gastroenterology & Urology
178d
Cleared
Jan 10, 2019
DIASAFEplusUS
Gastroenterology & Urology
132d
Cleared
May 24, 2018
Fresenius Liberty Select Cycler
Gastroenterology & Urology
27d
Cleared
May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter...
Gastroenterology & Urology
181d
Cleared
May 10, 2018
2008T BlueStar Hemodialysis Machine
Gastroenterology & Urology
132d
Cleared
May 01, 2018
Liberty Cycler Set
Gastroenterology & Urology
147d
Cleared
Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
Gastroenterology & Urology
78d
Cleared
Jan 24, 2018
Cycler Drain Bag Set
Gastroenterology & Urology
90d
Cleared
Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
Gastroenterology & Urology
141d
Cleared
Sep 15, 2017
Fresenius Liberty Select Cycler
Gastroenterology & Urology
102d
Cleared
May 18, 2017
bibag
Gastroenterology & Urology
231d
Cleared
Apr 26, 2016
2008K2 Hemodialysis Machine
Gastroenterology & Urology
148d
Cleared
Apr 15, 2016
CRIT-LINE III Blood Chamber II
Gastroenterology & Urology
28d
Cleared
Dec 10, 2015
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T...
Gastroenterology & Urology
266d
Cleared
Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
Gastroenterology & Urology
90d
Cleared
Jul 30, 2014
LIBERTY PDX CYCLER
Gastroenterology & Urology
89d
Cleared
Oct 11, 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
Gastroenterology & Urology
107d