Medical device manufacturer
Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. holds 103 FDA 510(k) clearances across 21 product codes. Median elapsed review time is 84 days. openFDA lists 56 recall records naming the company. FDA publishes it under 15 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 103
- Product codes
- 21
- Median review
- 84 days
- Recall records
- 56
How does FDA spell Datex-Ohmeda, Inc.?
FDA publishes this company under 15 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| DATEX--OHMEDA, INC. | device/enforcement | normalised |
| DATEX--OHMEDA, INC. | device/recall | normalised |
| Datex - Ohmeda, Inc | device/recall | normalised |
| Datex Ohmeda | device/510k | normalised |
| Datex Ohmeda, Inc. | device/510k | normalised |
| Datex Ohmeda, Inc. dba GE Healthcare | device/recall | normalised |
| Datex-Ohmeda | device/recall | normalised |
| Datex-Ohmeda | device/510k | normalised |
Showing 8 of 15.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Datex-Ohmeda, Inc. file in?
21 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 25 | 70 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 15 | 66 days | |
| CBK | Ventilator, Continuous, Facility Use | 14 | 104 days | |
| MSX | System, Network And Communication, Physiological Monitors | 9 | 43 days | |
| DQA | Oximeter | 7 | 28 days | |
| CAD | Vaporizer, Anesthesia, Non-Heated | 6 | 72 days | |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 89 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 138 days | |
| FMZ | Incubator, Neonatal | 3 | 114 days | |
| MLD | Monitor, St Segment With Alarm | 3 | 87 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 57 days | |
| OLW | Index-Generating Electroencephalograph Software | 2 | 90 days | |
| DPZ | Oximeter, Ear | 1 | 155 days | |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 57 days | |
| DSI | Detector And Alarm, Arrhythmia | 1 | 84 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 29 days | |
| FMT | Warmer, Infant Radiant | 1 | 114 days | |
| HGM | System, Monitoring, Perinatal | 1 | 158 days | |
| MRN | Apparatus, Nitric Oxide Delivery | 1 | 27 days | |
| NLF | Oximeter, Reprocessed | 1 | 253 days | |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 88 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Datex-Ohmeda, Inc. had a recall?
openFDA lists 56 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2357-2026Class IOpen, ClassifiedBTM
Blender 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.
Z-2358-2026Class IOpen, ClassifiedFMT
Blender 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.
Z-2359-2026Class IOpen, ClassifiedFMT
Blender 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.
Z-0047-2025Class IOpen, ClassifiedFMZ
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.
Z-0048-2025Class IOpen, ClassifiedFMZ
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.
Showing the 5 most recently initiated of 56.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Datex-Ohmeda, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | FMZ | 145 | |
| K231964 | Novii+ Wireless Patch System | HGM | 158 | |
| K213867 | Carestation 750/750c | BSZ | 473 | |
| K213553 | Giraffe Incubator Carestation CS1 | FMZ | 114 | |
| K213551 | Giraffe Omnibed Carestation CS1 | FMT | 114 | |
| K210384 | CARESCAPE R860 | CBK | 268 | |
| K172702 | Tec 820, Tec 850 | CAD | 119 | |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | BSZ | 120 | |
| K170872 | Aisys CS2 | BSZ | 145 | |
| K151570 | Carestation 620/650/650C | BSZ | 225 |
Source: openFDA device/510k · retrieved
Where is Datex-Ohmeda, Inc. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Datex-Ohmeda, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.