| Z-2151-2019 | Class II | Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal di | May 29, 2019 |
| Z-1699-2019 | Class III | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: | April 3, 2019 |
| Z-0658-2019 | Class II | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E | November 5, 2018 |
| Z-0516-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hem | October 9, 2018 |
| Z-0517-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hem | October 9, 2018 |
| Z-0518-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for | October 9, 2018 |
| Z-3195-2018 | Class II | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium U | July 13, 2018 |
| Z-3194-2018 | Class II | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Up | July 13, 2018 |
| Z-2110-2018 | Class II | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 | May 2, 2018 |
| Z-1365-2018 | Class II | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indi | January 24, 2018 |
| D-0604-2018 | Class II | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC | December 20, 2017 |
| Z-1278-2018 | Class II | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PL | December 14, 2017 |
| D-0827-2018 | Class II | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltha | November 13, 2017 |
| Z-0829-2018 | Class II | 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. | October 5, 2017 |
| Z-1010-2018 | Class II | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concent | September 29, 2017 |
| Z-1029-2017 | Class II | Fresenius 2008K@home Series : Hemodialysis System | December 21, 2016 |
| Z-1026-2017 | Class II | Fresenius 2008T Series Hemodialysis System | December 21, 2016 |
| Z-1027-2017 | Class II | Fresenius 2008K Series : Hemodialysis System | December 21, 2016 |
| Z-1028-2017 | Class II | Fresenius 2008K2 Series : Hemodialysis System | December 21, 2016 |
| Z-2044-2016 | Class II | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-in | May 24, 2016 |