Data / Medical devices / United States / Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc.: FDA-registered device maker in Wauwatosa, WI, United States, 23 510(k) clearances
Datex-Ohmeda, Inc. is registered with the FDA (registration 3014220748) in Wauwatosa, WI, United States. It lists 12 device types. The FDA files 23 510(k) clearances under its listings, the newest dated October 22, 2025. 3 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014220748
- Address
- 9900 Innovation Drive, Wauwatosa, WI, United States, 53226
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- November 5, 1992
- Registered through
- 2027
- Brand names listed
- 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in., 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in., 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in., 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in., 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in., 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Specification developer | accessdata.fda.gov |
| Incubator, Neonatal | FMZ | 2 | Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Specification developer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Specification developer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Specification developer | accessdata.fda.gov |
| Unit, Neonatal Phototherapy | LBI | 2 | Specification developer | accessdata.fda.gov |
| Uterine Electromyographic Monitor | OSP | 2 | Specification developer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Specification developer | accessdata.fda.gov |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 2 | Specification developer | accessdata.fda.gov |
| Warmer, Infant Radiant | FMT | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 22, 2025 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | FMZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| December 8, 2023 | K231964 | Novii+ Wireless Patch System | HGM | Substantially Equivalent | Datex Ohmeda | accessdata.fda.gov |
| March 2, 2022 | K213553 | Giraffe Incubator Carestation CS1 | FMZ | Substantially Equivalent | Datex Ohmeda, Inc. | accessdata.fda.gov |
| March 2, 2022 | K213551 | Giraffe Omnibed Carestation CS1 | FMT | Substantially Equivalent | Datex Ohmeda, Inc. | accessdata.fda.gov |
| February 12, 2021 | K201628 | Panda iRes Warmer, Giraffe Warmer | FMT | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 17, 2016 | K152814 | Giraffe OmniBed Carestation CS1 | FMZ | Substantially Equivalent | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | accessdata.fda.gov |
| December 31, 2015 | K152809 | Giraffe Incubator Carestation CS1 | FMZ | Substantially Equivalent | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | accessdata.fda.gov |
| August 27, 2014 | K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | OSP | Substantially Equivalent | Monica Healthcare, Ltd. | accessdata.fda.gov |
| February 5, 2013 | K123309 | GIRAFFE AND PANDA WARMERS | FMT | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| October 2, 2012 | K122267 | GIRAFFE AND PANDA WARMERS | FMT | Substantially Equivalent | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | accessdata.fda.gov |
| September 14, 2012 | K121625 | LULLABY TM WARMER | FMT | Substantially Equivalent | Wipro GE Healthcare Private, Ltd. | accessdata.fda.gov |
| June 8, 2012 | K120820 | GIRAFFE BLUE SPOT PT LITE | LBI | Substantially Equivalent | Lumitex, Inc. | accessdata.fda.gov |
| May 2, 2012 | K120168 | LULLABY LED PHOTTHERAPY SYSTEM | LBI | Substantially Equivalent | Wipro GE Healthcare Private, Ltd. | accessdata.fda.gov |
| July 21, 2010 | K101804 | GIRAFFE AND PANDA WARMERS | FMT | Substantially Equivalent | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | accessdata.fda.gov |
| July 21, 2010 | K101788 | GIRAFFE OMNIBED | FMZ | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| July 21, 2010 | K101778 | GIRAFFE INCUBATOR | FMZ | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| April 16, 2009 | K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | FMT | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| August 27, 2007 | K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | FMT | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| July 11, 2007 | K070377 | GIRAFFE AND PANDA WARMER | FMT | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| April 20, 2007 | K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | BTM | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| April 20, 2007 | K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | BTL | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| April 17, 2006 | K053568 | BILISOFT PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | Lumitex, Inc. | accessdata.fda.gov |
| May 9, 2002 | K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | FMZ | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 3, 2024 | 95282 | Class I | Ongoing | GE Heathcare Giraffe OmniBed; neo natal incubator | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose. | accessdata.fda.gov |
| June 6, 2023 | 95456 | Class I | Completed | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844 | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general sc | accessdata.fda.gov |
| May 19, 2023 | 92454 | Class II | Ongoing | Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNI | GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices | accessdata.fda.gov |
Compare with other makers
- All makers of System, Monitoring, Perinatal
- All makers of Scale, Patient
- All makers of Incubator, Neonatal
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Cable, Electrode
- All makers of Warmer, Infant Radiant
Updated October 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.