Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE HealthCareLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 8 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Datex-Ohmeda with 105 510(k) clearances and 30 device recalls. The most recent is a 510(k) clearance dated Aug 10, 2026: Novii+ Wireless Patch System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 10, 2026 | Novii+ Wireless Patch SystemK254036 · HGM | 510(k) clearances |
| Jul 28, 2026 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)K260326 · FMZ | 510(k) clearances |
| May 8, 2026 | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002,Class I · Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen con | Device recalls |
| May 8, 2026 | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1Class I · Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen con | Device recalls |
| May 8, 2026 | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installedClass I · Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen con | Device recalls |
| Oct 22, 2025 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)K251663 · FMZ | 510(k) clearances |
| Dec 8, 2023 | Novii+ Wireless Patch SystemK231964 · HGM | 510(k) clearances |
| Mar 28, 2023 | Carestation 750/750cK213867 · BSZ | 510(k) clearances |
| Mar 2, 2022 | Giraffe Incubator Carestation CS1K213553 · FMZ | 510(k) clearances |
| Mar 2, 2022 | Giraffe Omnibed Carestation CS1K213551 · FMT | 510(k) clearances |
| Nov 4, 2021 | CARESCAPE R860K210384 · CBK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
