| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-04-30 | K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | General Hospital |
| 2026-03-16 | K252282 | SurgiCount+ System | Stryker Instruments | General Hospital |
| 2024-04-02 | DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | General Hospital |
| 2024-01-11 | K232250 | SurgiCount+ System | Stryker Instruments | General Hospital |
| 2019-11-04 | K190013 | WellDoc BlueStar | WellDoc, Inc. | General Hospital |
| 2016-08-05 | K160338 | Triton System | GAUSS SURGICAL INC. | General Hospital |