| 2026-06-05 |
K253162 |
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) |
FLL |
Class II |
General Hospital |
| 2026-04-14 |
K260931 |
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) |
DQA |
— |
— |
| 2026-01-09 |
K253964 |
Disposable Neonatal NIBP Cuff (U1681S-C51N) |
DXQ |
Class II |
Cardiovascular |
| 2025-12-01 |
K251696 |
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) |
DQA |
— |
— |
| 2025-12-01 |
K251691 |
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) |
DQA |
— |
— |
| 2025-11-18 |
K251695 |
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) |
DQA |
— |
— |
| 2025-11-18 |
K251693 |
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) |
DQA |
— |
— |
| 2025-08-13 |
K250931 |
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) |
DQA |
— |
— |
| 2025-07-15 |
K251045 |
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) |
DXQ |
Class II |
Cardiovascular |
| 2025-02-20 |
K243086 |
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) |
DQA |
— |
— |
| 2025-02-06 |
K242580 |
Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) |
DQA |
— |
— |
| 2022-12-19 |
K222213 |
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) |
DQA |
— |
— |
| 2021-03-04 |
K210019 |
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ |
CCK |
Class II |
Anesthesiology |