Medical device manufacturer
Ohmeda Medical
Ohmeda Medical holds 123 FDA 510(k) clearances across 39 product codes. Median elapsed review time is 79 days. openFDA lists 15 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 123
- Product codes
- 39
- Median review
- 79 days
- Recall records
- 15
How does FDA spell Ohmeda Medical?
FDA publishes this company under 6 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 |
|---|---|---|
| Ohmeda Medical | device/enforcement | normalised |
| Ohmeda Medical | device/510k | normalised |
| Ohmeda Medical | device/recall | normalised |
| Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | device/510k | normalised |
| Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | device/510k | normalised |
| Ohmeda Medical, A division of Datex-Ohmeda, Inc. | device/recall | normalised |
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 Ohmeda Medical file in?
39 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 17 | 132 days | |
| FMZ | Incubator, Neonatal | 17 | 79 days | |
| FMT | Warmer, Infant Radiant | 12 | 56 days | |
| CBK | Ventilator, Continuous, Facility Use | 10 | 91 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 | 137 days | |
| DQA | Oximeter | 5 | 129 days | |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 4 | 7 days | |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 4 | 73 days | |
| FMG | Stopcock, I.V. Set | 4 | 77 days | |
| CAD | Vaporizer, Anesthesia, Non-Heated | 3 | 332 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 238 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 121 days | |
| LBI | Unit, Neonatal Phototherapy | 3 | 108 days | |
| BSF | Absorber, Carbon-Dioxide | 2 | 53 days | |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 | 88 days | |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 85 days | |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 17 days | |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 8 days | |
| BTI | Compressor, Air, Portable | 1 | 7 days | |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 25 days | |
| BZA | Connector, Airway (Extension) | 1 | 75 days | |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 26 days | |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 56 days | |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 1 | 78 days | |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 1 | 73 days |
Showing the 25 they file in most, of 39.
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 Ohmeda Medical had a recall?
openFDA lists 15 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0041-2020Class IITerminatedFMZ
GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
Z-1181-2018Class IITerminatedFOX
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Z-1501-2017Class IITerminatedKZF
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Z-1502-2017Class IITerminatedFMZ
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Z-1503-2017Class IITerminatedLBI
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Showing the 5 most recently initiated of 15.
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 Ohmeda Medical cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K152814 | Giraffe OmniBed Carestation CS1 | FMZ | 171 | |
| K152809 | Giraffe Incubator Carestation CS1 | FMZ | 94 | |
| K123309 | GIRAFFE AND PANDA WARMERS | FMT | 104 | |
| K122267 | GIRAFFE AND PANDA WARMERS | FMT | 64 | |
| K101804 | GIRAFFE AND PANDA WARMERS | FMT | 23 | |
| K101788 | GIRAFFE OMNIBED | FMZ | 26 | |
| K101778 | GIRAFFE INCUBATOR | FMZ | 26 | |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | FMT | 30 | |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | FMT | 24 | |
| K070377 | GIRAFFE AND PANDA WARMER | FMT | 153 |
Source: openFDA device/510k · retrieved
Watch what Ohmeda Medical 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.