← Every applicant
Fresenius Medical Care Renal Therapies Group, LLC FDA Approvals
0 new drug approvals and 28 device clearances on file. Matched by name to FMS.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Careflux H60;Careflux H70;Careflux V500510(k)Jul 24, 2026Gastroenterology, Urology |
| NxStage System One with NxView510(k)May 15, 2026Gastroenterology, Urology |
| multiFlux 130 (F00013123); multiFlux 160 (F00013124)510(k)Feb 10, 2026Gastroenterology, Urology |
| NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)510(k)Jan 29, 2026Gastroenterology, Urology |
| FX CorAL 40; FX CorAL 50510(k)Dec 18, 2025Gastroenterology, Urology |
| BCM2-Body Composition Monitor510(k)Nov 24, 2025Cardiovascular |
| AquaC UNO H510(k)Nov 14, 2025Gastroenterology, Urology |
| DIASAFEplusUS (F00013010)510(k)Oct 9, 2025Gastroenterology, Urology |
| Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)510(k)Sep 9, 2025Gastroenterology, Urology |
| 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)510(k)Jun 13, 2025Gastroenterology, Urology |
| 5008X Hemodialysis System510(k)May 30, 2025Gastroenterology, Urology |
| Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)510(k)Apr 4, 2025Gastroenterology, Urology |
| staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch510(k)Apr 3, 2025Gastroenterology, Urology |
| FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)510(k)Mar 21, 2025Gastroenterology, Urology |
| FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)510(k)Feb 28, 2025Gastroenterology, Urology |
| AquaBplus; AquaB LITE510(k)Jun 13, 2024Gastroenterology, Urology |
| multiFlux 1000 (F00012408)510(k)May 31, 2024Gastroenterology, Urology |
| pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)510(k)May 10, 2024Gastroenterology, Urology |
| Novalung ultimate kit (US)510(k)Apr 15, 2024Cardiovascular |
| 2008T BlueStar Hemodialysis Machine510(k)Dec 6, 2023Gastroenterology, Urology |
| pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504510(k)Dec 1, 2023Gastroenterology, Urology |
| CombiSet Hemodialysis Blood Tubing Set510(k)May 31, 2023Gastroenterology, Urology |
| FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000510(k)May 11, 2023Gastroenterology, Urology |
| multiFiltratePRO System510(k)Dec 16, 2022Gastroenterology, Urology |
| Fresenius Liberty Select Cycler510(k)Oct 31, 2022Gastroenterology, Urology |
| 2008T BlueStar Hemodailysis Machine510(k)Oct 27, 2022Gastroenterology, Urology |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate510(k)May 12, 2022Gastroenterology, Urology |
| Lilliput APD System510(k)Apr 15, 2022Gastroenterology, Urology |