Skip to the page
Get started – free

Data / Medical devices / United States / Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc.: FDA-registered device maker in Waukesha, WI, United States, 25 510(k) clearances

Datex-Ohmeda, Inc. is registered with the FDA (registration 3036470679) in Waukesha, WI, United States. It lists 12 device types. The FDA files 25 510(k) clearances under its listings, the newest dated August 10, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Datex-Ohmeda, Inc.
FDA registration number
3036470679
Address
3114 N Grandview Blvd, Waukesha, WI, United States, 53188
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

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Specification developeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Specification developeraccessdata.fda.gov
Incubator, NeonatalFMZ2Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Scale, PatientFRW1Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Specification developeraccessdata.fda.gov
Unit, Neonatal PhototherapyLBI2Specification developeraccessdata.fda.gov
Uterine Electromyographic MonitorOSP2Specification developeraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Specification developeraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Specification developeraccessdata.fda.gov
Warmer, Infant RadiantFMT2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 10, 2026K254036Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
July 28, 2026K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZSubstantially EquivalentDatex-Ohmeda, Inc.accessdata.fda.gov
October 22, 2025K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZSubstantially EquivalentDatex-Ohmeda, Inc.accessdata.fda.gov
December 8, 2023K231964Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmedaaccessdata.fda.gov
March 2, 2022K213553Giraffe Incubator Carestation CS1FMZSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
March 2, 2022K213551Giraffe Omnibed Carestation CS1FMTSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
February 12, 2021K201628Panda iRes Warmer, Giraffe WarmerFMTSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 17, 2016K152814Giraffe OmniBed Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Companyaccessdata.fda.gov
December 31, 2015K152809Giraffe Incubator Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
August 27, 2014K140862MONICA NOVII WIRELESS PATCH SYSTEMOSPSubstantially EquivalentMonica Healthcare, Ltd.accessdata.fda.gov
February 5, 2013K123309GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
October 2, 2012K122267GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
September 14, 2012K121625LULLABY TM WARMERFMTSubstantially EquivalentWipro GE Healthcare Private, Ltd.accessdata.fda.gov
June 8, 2012K120820GIRAFFE BLUE SPOT PT LITELBISubstantially EquivalentLumitex, Inc.accessdata.fda.gov
May 2, 2012K120168LULLABY LED PHOTTHERAPY SYSTEMLBISubstantially EquivalentWipro GE Healthcare Private, Ltd.accessdata.fda.gov
July 21, 2010K101804GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
July 21, 2010K101788GIRAFFE OMNIBEDFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
July 21, 2010K101778GIRAFFE INCUBATORFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 16, 2009K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
August 27, 2007K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
July 11, 2007K070377GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 20, 2007K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTMSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 20, 2007K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTLSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 17, 2006K053568BILISOFT PHOTOTHERAPY SYSTEMLBISubstantially EquivalentLumitex, Inc.accessdata.fda.gov
May 9, 2002K020543OHMEDA MEDICAL GIRAFFE OMNIBEDFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 8, 202699036Class IOngoingGiraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed durinBlender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.accessdata.fda.gov

Compare with other makers

Updated August 10, 2026. 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.