EDAN Diagnostics, Inc.
San Diego, CA, US
EDAN Diagnostics, Inc. appears in FDA device records in San Diego, CA. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 18 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009499478 | 3009499478 | EDAN Diagnostics, Inc. | 9918 Via Pasar, San Diego, CA 92126 US | 2026 | and 25 more, listed in full below |
| 3039433788 | 3039433788 | Edan Diagnostics, Inc. | 5995 Pacific Center Blvd Ste 105, San Diego, CA 92121 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- GXYElectrode, Cutaneous
- HEPMonitor, Blood-Flow, Ultrasonic
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- KNGMonitor, Ultrasonic, Fetal
- DQAOximeter
- DSBPlethysmograph, Impedance
- DSHRecorder, Magnetic Tape, Medical
- BZKSpirometer, Monitoring (W/Wo Alarm)
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1155-2026 | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1154-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1153-2026 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1152-2026 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1151-2026 | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1150-2026 | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1149-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1148-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1147-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1146-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1145-2026 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1144-2026 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1143-2026 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1142-2026 | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1141-2026 | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1140-2026 | Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | Class II | Open, Classified | |
| Z-1256-2020 | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.) | Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA. | Class II | Terminated | |
| Z-2388-2016 | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). | Incorrect CO2 readings with some patient monitors. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain