Fresenius Medical Care North America - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
Fresenius Medical Care North America has 43 FDA 510(k) cleared gastroenterology & urology devices. Based in Lexington, US.
Latest FDA clearance: Sep 2025. Active since 1998.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Fresenius Medical Care North America
43 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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