Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...
50
Total
50
Cleared
0
Denied
Fresenius Medical Care Renal Therapies Group, LLC has 50 FDA 510(k) cleared gastroenterology & urology devices. Based in Waltham, US.
Latest FDA clearance: Feb 2026. Active since 2013.
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 Renal...
50 devices
Cleared
Feb 10, 2026
multiFlux 130 (F00013123)
Gastroenterology & Urology
189d
Cleared
Jan 29, 2026
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
Gastroenterology & Urology
114d
Cleared
Dec 18, 2025
FX CorAL 40
Gastroenterology & Urology
36d
Cleared
Nov 24, 2025
BCM2-Body Composition Monitor
Gastroenterology & Urology
266d
Cleared
Nov 14, 2025
AquaC UNO H
Gastroenterology & Urology
269d
Cleared
Oct 09, 2025
DIASAFEplusUS (F00013010)
Gastroenterology & Urology
115d
Cleared
Sep 09, 2025
Bicarby Dialysate RFP-404 (RFP-404-W)
Gastroenterology & Urology
60d
Cleared
Jun 13, 2025
2008T HD SYS. CDX BLUESTAR (191124)
Gastroenterology & Urology
246d
Cleared
May 30, 2025
5008X Hemodialysis System
Gastroenterology & Urology
199d
Cleared
Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
Gastroenterology & Urology
116d
Cleared
Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
Gastroenterology & Urology
50d
Cleared
Mar 21, 2025
FX CorAL 40 (F00009214)
Gastroenterology & Urology
252d
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