GE Healthcare

FDA records resolved to GE Healthcare carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

• Datex Ohmeda, Inc. dba GE Healthcarerecall
• Datex-Ohmeda, Inc.registration, 510(k), enforcement report, recall
• Del Mar Reynolds Medical, Ltd.510(k), enforcement report, recall
• Ge Healthcare Integrated IT Solutions510(k), recall
• GE Healthcare Itenforcement report, recall
• GE Healthcare Manufacturing LLCregistration
• Ge Medical Systems Information Tenforcement report, recall
• GE Medical Systems Information Tecnologyrecall
• GE Medical Systems Ultrasound & Primary Care Diagnostics, LLenforcement report, recall
• GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCregistration, 510(k)
• Ge Medical Systems, LLCregistration, 510(k), PMA, enforcement report, recall
• Ge Oec Medical Systems, Inc.registration, 510(k), enforcement report, recall
• General Electric Med Systems LLCenforcement report, recall
• General Electric Med. Sys. Ultrasoundrecall
• Oec Medical Systems, Inc.510(k), recall
• Ohmeda Medical510(k), enforcement report, recall
• Ohmeda Medical, A Div of Datex-Ohmeda , Increcall
• Ohmeda Medical, A Division of Datex-Ohmeda, Inc.510(k), recall
• Spacelabs Healthcare, Incorporatedrecall
• Spacelabs Healthcare, Ltd.registration, 510(k), enforcement report, recall
• Spacelabs Medical Incorporatedrecall
• Spacelabs Medical, Inc.510(k), recall

FDA records hold 888 510(k) clearances for GE Healthcare between 1984 and 2026. The busiest year on record is 2005, with 47. The most recent is 2026, with 17.

Registration numbers link to the FDA registration and listing record for that establishment.

• BSFAbsorber, Carbon-Dioxide
• CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
• CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
• CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
• CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
• CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
• CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
• CBNApparatus, Gas-Scavenging
• GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
• BYEAttachment, Breathing, Positive End Expiratory Pressure
• DXQBlood Pressure Cuff
• IKDCable, Electrode
• DSACable, Transducer And Electrode, Patient, (Including Connector)
• FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
• EYCCatheter, Upper Urinary Tract
• CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
• BTICompressor, Air, Portable
• DSKComputer, Blood-Pressure
• DXGComputer, Diagnostic, Pre-Programmed, Single-Function
• DQKComputer, Diagnostic, Programmable
• BZAConnector, Airway (Extension)
• FLLContinuous Measurement Thermometer
• DSIDetector And Alarm, Arrhythmia
• HCCDevice, Biofeedback
• DXJDisplay, Cathode-Ray Tube, Medical
• DPSElectrocardiograph
• GXYElectrode, Cutaneous
• DRXElectrode, Electrocardiograph
• CAHFilter, Bacterial, Breathing-Circuit
• CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
• GWQFull-Montage Standard Electroencephalograph
• BSZGas-Machine, Anesthesia
• CAWGenerator, Oxygen, Portable
• FMZIncubator, Neonatal
• DWSInstruments, Surgical, Cardiovascular
• DYBIntroducer, Catheter
• GCJLaparoscope, General & Plastic Surgery
• BZRMixer, Breathing Gases, Anesthesia Inhalation
• CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
• FMINeedle, Hypodermic, Single Lumen
• DQAOximeter
• DPZOximeter, Ear
• FRNPump, Infusion
• DSFRecorder, Paper Chart
• HIOSampler, Amniotic Fluid (Amniocentesis Tray)
• FRWScale, Patient
• BZKSpirometer, Monitoring (W/Wo Alarm)
• FOXStand, Infusion
• FMGStopcock, I.V. Set
• DXNSystem, Measurement, Blood-Pressure, Non-Invasive
• HGMSystem, Monitoring, Perinatal
• DXOTransducer, Pressure, Catheter Tip
• DXHTransmitters And Receivers, Electrocardiograph, Telephone
• BTRTube, Tracheal (W/Wo Connector)
• CADVaporizer, Anesthesia, Non-Heated
• CBKVentilator, Continuous, Facility Use
• BTMVentilator, Emergency, Manual (Resuscitator)
• BTLVentilator, Emergency, Powered (Resuscitator)
• FMTWarmer, Infant Radiant
• FRGWrap, Sterilization