Datex-Ohmeda, Inc. (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, monitoring, perinatal
Datex-Ohmeda, Inc. (Waukesha, Wisconsin): 3 new FDA device listings, incl. system, monitoring, perinatal. Its amount of 3 is above the median of 1 (77th percentile). Dated 56 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 22 related WI DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Datex-Ohmeda, Inc. |
| Owner / operator | GE HealthCare Technologies Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Waukesha, WI, US |
| New listings | 3 |
| Devices | System, Monitoring, Perinatal; Incubator, Neonatal; Warmer, Infant Radiant |
| Product codes | HGM, FMZ, FMT |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology, General Hospital |
| Brand names | Novii+ Pod; Novii+ Interface; Novii+ Wireless Patch System; Giraffe Incubator Carestation CS1; Giraffe Omnibed Carestation CS1 |
| First new listing | 2026-09-09 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 3036470679 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (23 WI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-09
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (WI first): GE Medical Systems Information Technologies, Inc. (specifica · GE Medical Systems Information Technologies, Inc. (specifica · Icp, Inc. (specification developer, Green Bay, WI) · Merz North America, Inc. (other, Sturtevant, WI) · GE Medical Systems Ultrasound and Primary Care Diagnostics, · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Datex-Ohmeda, Inc. and 23 Wisconsin peers
- Wisconsin DeviceEstablishmentPulse records like this one: 23
- Datex-Ohmeda, Inc.'s amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $4,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Datex-Ohmeda, Inc. in Waukesha, Wisconsin?
Datex-Ohmeda, Inc. (Waukesha, WI), a specification developer (outsources manufacturing), added 3 FDA device listings on 2026-09-09.
How does Datex-Ohmeda, Inc. compare to other Wisconsin DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 56 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Datex-Ohmeda, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Waukesha, WI | 3 | 77th | 2026-09-09 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Wisconsin
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.