| Careflux H60;Careflux H70;Careflux V500 (K261267) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 |
| NxStage System One with NxView (K252377) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 |
| multiFlux 130 (F00013123); multiFlux 160 (F00013124) (K252459) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 |
| NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 |
| FX CorAL 40; FX CorAL 50 (K253518) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 |
| BCM2-Body Composition Monitor (K250634) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| AquaC UNO H (K250471) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| DIASAFEplusUS (F00013010) (K251851) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| 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) (K252180) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 |
| 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) (K243237) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 |
| 5008X Hemodialysis System (K243505) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 |
| 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) (K243786) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 |
| stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 |
| FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (K242053) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 |
| 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) (K243874) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 |
| AquaBplus; AquaB LITE (K232953) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| multiFlux 1000 (F00012408) (K240394) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 |
| pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| 2008T BlueStar Hemodialysis Machine (K231125) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 |
| pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 |
| CombiSet Hemodialysis Blood Tubing Set (K213992) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 |
| FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (K220721) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-11 |
| multiFiltratePRO System (K220281) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-12-16 |
| Fresenius Liberty Select Cycler (K222318) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 |
| 2008T BlueStar Hemodailysis Machine (K222952) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K212620) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 |
| Lilliput APD System (K212522) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 |
| Optiflux Series of Dialyzers F160NR, F180NR, F200NR (K203062) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 |
| Optiflux F180NR Dialyzer (K192707) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 |
| CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (K201207) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate (K192209) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K192017) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 |
| NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) (K191474) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-24 |
| Novalung System (K191407) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |
| Hemoflow F3 and F4 Dialyzers (K190459) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| DIASAFEplusUS (K182367) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| Fresenius Liberty Select Cycler (K181108) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 |
| stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (K173593) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 |
| 2008T BlueStar Hemodialysis Machine (K173972) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 |
| Liberty Cycler Set (K173718) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 |
| Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-14 |
| Cycler Drain Bag Set (K173363) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 |
| CAREline Airless Hemodialysis Blood Tubing Sets (K172238) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| Fresenius Liberty Select Cycler (K171652) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 |
| bibag (K162716) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-05-18 |
| 2008K2 Hemodialysis Machine (K153449) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 |
| CRIT-LINE III Blood Chamber II (K160749) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708) | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K141281) | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 |
| LIBERTY PDX CYCLER (K141145) | Fresenius Medical Care Renal Therapies Group, LLC | 2014-07-30 |
| 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) (K131908) | Fresenius Medical Care Renal Therapies Group, LLC | 2013-10-11 |