Total clearances
4
2022-03-02 → 2026-08-10
Name variants in FDA filings: Datex Ohmeda / Datex Ohmeda, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| HGM |
System, Monitoring, Perinatal |
Class II |
Obstetrics/Gynecology |
2 |
2026-08-10 |
| FMT |
Warmer, Infant Radiant |
Class II |
General Hospital |
1 |
2022-03-02 |
| FMZ |
— |
— |
— |
1 |
2022-03-02 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-08-10 |
K254036 |
Novii+ Wireless Patch System |
HGM |
Class II |
Obstetrics/Gynecology |
| 2023-12-08 |
K231964 |
Novii+ Wireless Patch System |
HGM |
Class II |
Obstetrics/Gynecology |
| 2022-03-02 |
K213553 |
Giraffe Incubator Carestation CS1 |
FMZ |
— |
— |
| 2022-03-02 |
K213551 |
Giraffe Omnibed Carestation CS1 |
FMT |
Class II |
General Hospital |