| Z-1864-2025 | Class II | NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, | April 28, 2025 |
| Z-2160-2024 | Class II | NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RF | May 14, 2024 |
| Z-0697-2020 | Class II | Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model N | August 27, 2019 |
| Z-1706-2019 | Class II | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indi | April 11, 2019 |
| Z-1707-2019 | Class II | NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated fo | April 11, 2019 |
| Z-0506-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B | October 17, 2018 |
| Z-0505-2019 | Class II | NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solu | October 17, 2018 |
| Z-0502-2019 | Class II | NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solu | October 17, 2018 |
| Z-0503-2019 | Class II | NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B So | October 17, 2018 |
| Z-0501-2019 | Class II | NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solu | October 17, 2018 |
| Z-0507-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B | October 17, 2018 |
| Z-0504-2019 | Class II | NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solu | October 17, 2018 |
| Z-0500-2019 | Class II | NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B S | October 17, 2018 |
| Z-2793-2018 | Class II | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The | June 11, 2018 |
| Z-0811-2018 | Class II | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-3 | January 29, 2018 |
| Z-1132-2018 | Class II | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One | November 10, 2017 |
| Z-0336-2016 | Class II | NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. | October 29, 2015 |
| Z-0337-2016 | Class II | NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4 | October 29, 2015 |
| Z-0335-2016 | Class II | NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. | October 29, 2015 |
| Z-0326-2016 | Class II | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 | October 29, 2015 |