| Z-2196-2014 | Class II | Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouch | July 18, 2014 |
| Z-2202-2014 | Class II | Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carto | July 18, 2014 |
| Z-2199-2014 | Class II | Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 | July 18, 2014 |
| Z-2201-2014 | Class II | Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per ca | July 18, 2014 |
| Z-2198-2014 | Class II | Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carto | July 18, 2014 |
| Z-2203-2014 | Class II | Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carto | July 18, 2014 |
| Z-2205-2014 | Class II | Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per ca | July 18, 2014 |
| Z-2194-2014 | Class II | Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per c | July 18, 2014 |
| Z-2206-2014 | Class II | PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per ca | July 18, 2014 |
| Z-2195-2014 | Class II | Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 | July 18, 2014 |
| Z-2197-2014 | Class II | Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per | July 18, 2014 |
| Z-2207-2014 | Class II | X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 | July 18, 2014 |
| Z-2204-2014 | Class II | Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per ca | July 18, 2014 |
| Z-2200-2014 | Class II | Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 | July 18, 2014 |
| Z-2193-2014 | Class II | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches | July 18, 2014 |
| Z-1643-2014 | Class II | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intende | April 16, 2014 |
| Z-1644-2014 | Class II | Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. In | April 16, 2014 |
| Z-1455-2014 | Class II | Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410 | December 9, 2013 |