| Gas-Flow Meter Gfl 10 | K822820 | FDA 510(k) | Class II | Active |
| Ak-10 | K771227 | FDA 510(k) | Class II | Active |
| Gambro A-V Fistula Needle Set | K802956 | FDA 510(k) | Class II | Active |
| Phoenix Hemodialysis Delivery System, Version 3.35 | K070643 | FDA 510(k) | Class II | Active |
| Gambro Gf-80-M, Gf-80-H Hemodialyzer | K820304 | FDA 510(k) | Class II | Active |
| Dialyzer, Ultradiffuser, Disposable | K770858 | FDA 510(k) | Class II | Active |
| Engstrom Edith Models 500, 1000, 1500 & 1500f | K864095 | FDA 510(k) | Class I | Active |
| Gambro Analyz Mon Glucose/Am-G & Disp Am-G Tub Set | K860682 | FDA 510(k) | Class II | Active |
| Gf120h Dialyzer | K801045 | FDA 510(k) | Class II | Active |
| Gambro Blood Concentrator Sets 16, 60, 200 | K854309 | FDA 510(k) | Class II | Active |
| Gambro Bicart System | K873155 | FDA 510(k) | Class II | Active |
| Lundia 10-2-N Parallel Flow Dialyzer | K830905 | FDA 510(k) | Class II | Active |
| Lundia Plate Disposable Dialyzer | K780700 | FDA 510(k) | Class II | Active |
| Pump Modules Pmo Lo-110-Pmd 10-210 | K822071 | FDA 510(k) | Class II | Active |
| Engstrom Eliza Duo Co2 & O2 Analyz | K840645 | FDA 510(k) | Class II | Active |
| Gambro Digital Telethermometer Tth 10-200 | K852455 | FDA 510(k) | Class I | Active |
| Gambro Bicarbonate Module, Bcm-10 | K810127 | FDA 510(k) | Class II | Active |
| Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer | K883589 | FDA 510(k) | Class II | Active |
| Gambro Multipurpose System Mps-10 | K881270 | FDA 510(k) | Class II | Active |
| Gambro Alwall Gfe 8 & 9 Hollow Fiber Dialyzer | K890111 | FDA 510(k) | Class II | Active |
| Craftemp Et 3045 Electronic Thermometry System | K852454 | FDA 510(k) | Class II | Active |
| Gambro Lundia Plate High Flux Hemodial- | K801479 | FDA 510(k) | Class II | Active |
| Engstrom Erica Ii Respirator | K862025 | FDA 510(k) | Class II | Active |
| Gambro Blood Level Detector Lcs 10 | K822821 | FDA 510(k) | Class II | Active |
| Exalis, Software Version 1.15 | K083158 | FDA 510(k) | Class II | Active |
| Gf 120m, 120h, 180m & 180h Hollow Fiber Dialyzers | K880084 | FDA 510(k) | Class II | Active |
| Hemofiltration System 10 | K862716 | FDA 510(k) | Class II | Active |
| Fh 101, Fh 202 & Fh 303 Fiber Hemofilter | K830284 | FDA 510(k) | Class II | Active |
| Gambro Pressure Monitor Prm 10 | K822822 | FDA 510(k) | Class II | Active |
| Lundia 10-5 N Parallel Flow Dialyzer | K822049 | FDA 510(k) | Class II | Active |
| Gf-180-M & Gf-180-H Hemodialyzers | K821367 | FDA 510(k) | Class II | Active |
| Winged Fistula Needle | K760935 | FDA 510(k) | Class II | Active |
| Gambro Lundia Plate High Flux Dialyzer | K811944 | FDA 510(k) | Class II | Active |
| Gambro Lundia Major High Flux Hemodialyz | K801480 | FDA 510(k) | Class II | Active |
| Gf-180-L Hollow Fiber Hemodialysis | K831606 | FDA 510(k) | Class II | Active |
| Blood Monitor Bmm 10-4 | K831404 | FDA 510(k) | Class II | Active |
| Gambro Lundia 10-1l, 1n, 1h, 3h, 4n, 4h, 5h, 6n | K862840 | FDA 510(k) | Class II | Active |
| Gambro Venous Blood Line | K770691 | FDA 510(k) | Class II | Active |
| Gambro Lundia 10 3n Parallel Flow Dial | K820769 | FDA 510(k) | Class II | Active |
| Hyper-Hypothermia Unit Hypo 10-200 | K831677 | FDA 510(k) | Class II | Active |
| Crafon Arthroscopy Lines | K830673 | FDA 510(k) | Class II | Active |
| Gambro Alwall Gfs Plus 11, 16 & 20 Hollow Fiber | K902481 | FDA 510(k) | Class II | Active |
| Gambro Ak-10-Udm-10-A Ultradiffusion | K800425 | FDA 510(k) | Class II | Active |
| Gambro Lundia Plate Disp. Dialyzer | K802389 | FDA 510(k) | Class II | Active |
| Hemofiltration System | K831784 | FDA 510(k) | Class II | Active |