Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...
Recent clearances: NxStage System One with NxView, multiFlux 130 (F00013123), NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
51
Total
51
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fresenius Medical Care Renal Therapies Group, LLC Gastroenterology & Urology ✕
49 devices
Cleared
May 15, 2026
NxStage System One with NxView
Gastroenterology & Urology
289d
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
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