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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.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
Ohmeda Medicaldevice/enforcementnormalised
Ohmeda Medicaldevice/510knormalised
Ohmeda Medicaldevice/recallnormalised
Ohmeda Medical, A Division of Datex-Ohmeda, Inc.device/510knormalised
Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Companydevice/510knormalised
Ohmeda Medical, A division of Datex-Ohmeda, Inc.device/recallnormalised

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.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
BSZGas-Machine, Anesthesia17132 days
FMZIncubator, Neonatal1779 days
FMTWarmer, Infant Radiant1256 days
CBKVentilator, Continuous, Facility Use1091 days
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase6137 days
DQAOximeter5129 days
BZKSpirometer, Monitoring (W/Wo Alarm)47 days
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)473 days
FMGStopcock, I.V. Set477 days
CADVaporizer, Anesthesia, Non-Heated3332 days
DXNSystem, Measurement, Blood-Pressure, Non-Invasive3238 days
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3121 days
LBIUnit, Neonatal Phototherapy3108 days
BSFAbsorber, Carbon-Dioxide253 days
BTLVentilator, Emergency, Powered (Resuscitator)288 days
BTMVentilator, Emergency, Manual (Resuscitator)285 days
BYEAttachment, Breathing, Positive End Expiratory Pressure217 days
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase28 days
BTICompressor, Air, Portable17 days
BTRTube, Tracheal (W/Wo Connector)125 days
BZAConnector, Airway (Extension)175 days
BZRMixer, Breathing Gases, Anesthesia Inhalation126 days
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)156 days
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated178 days
CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling173 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?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K152814Giraffe OmniBed Carestation CS1FMZ171
K152809Giraffe Incubator Carestation CS1FMZ94
K123309GIRAFFE AND PANDA WARMERSFMT104
K122267GIRAFFE AND PANDA WARMERSFMT64
K101804GIRAFFE AND PANDA WARMERSFMT23
K101788GIRAFFE OMNIBEDFMZ26
K101778GIRAFFE INCUBATORFMZ26
K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMT30
K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMT24
K070377GIRAFFE AND PANDA WARMERFMT153

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.