Fresenius Medical Care North America - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
FDA 510(k) cleared devices by Fresenius Medical Care North America Gastroenterology & Urology ✕
42 devices
Cleared
Sep 09, 2025
AquaA
Gastroenterology & Urology
60d
Cleared
Apr 06, 2017
Optiflux dialyzer
Gastroenterology & Urology
211d
Cleared
Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
Gastroenterology & Urology
29d
Cleared
Oct 29, 2015
Optiflux dialyzer
Gastroenterology & Urology
69d
Cleared
Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
Gastroenterology & Urology
445d
Cleared
Aug 29, 2013
FRESENIUS DRY ACID DISSOLUTION UNITS
Gastroenterology & Urology
87d
Cleared
Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
Gastroenterology & Urology
187d
Cleared
Dec 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
Gastroenterology & Urology
217d
Cleared
Nov 09, 2012
CRIT-LINE CLIP (CLIC)
Gastroenterology & Urology
161d
Cleared
Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
Gastroenterology & Urology
30d
Cleared
Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
Gastroenterology & Urology
30d
Cleared
Feb 03, 2011
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
Gastroenterology & Urology
1491d
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