Edan Instruments, Inc.
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Part of Edan Instruments, Inc.
Edan Instruments, Inc. is a medical device manufacturer, with 399 devices listed in FDA GUDID and EUDAMED (FDA Class II and I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 399
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 399
- EUDAMED 197
- Device classes
- FDA Class II 393
- FDA Class I 1
- FDA recalls
- Sites and related companies
- Identifiers
- DUNS 529173163
At a glance
Market reach
- United States
- FDA recalls
What Edan Instruments, Inc. makes
Edan Instruments, Inc. manufactures reusable electrocardiographic lead sets, reusable blood pressure cuffs, and reusable patient temperature probes. Their product line includes hand-held extracorporeal ultrasound imaging transducers, general-purpose ultrasound imaging systems, and reusable positioners for ultrasound tracking. They also produce professional multichannel electrocardiographs and general-purpose multi-parameter bedside monitors, alongside specialized devices like ultrasonic pocket dopplers and needle guide bracket kits for diagnostic imaging.
All listed devices fall under FDA’s Class II regulatory category and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to U.S. medical device regulations.
Catalogue
Search and filter all 399 devicesShowing 1-50 of 399
Company details
- DUNS number
- 529173163
FDA recalls
FDA recall records list 1 recall initiated by Edan Instruments, Inc., initiated on 2010-09-10. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 10 Sep 2010 Z-0041-2012 Unclassified (pre-2012) Terminated The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue.
Full distribution text
- 10 Sep 2010 Z-0041-2012 Unclassified (pre-2012) Terminated The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue.
Frequently asked questions
How many devices does Edan Instruments, Inc. have in the registry?
The registry currently lists 399 devices for Edan Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edan Instruments, Inc.'s devices?
Among its 50 most recently registered devices, Edan Instruments, Inc. has devices listed in EUDAMED (17 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Edan Instruments, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Edan Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Edan Instruments, Inc.?
FDA recall records list 1 recall initiated by Edan Instruments, Inc., the most recent initiated on 10 Sep 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Edan Instruments, Inc. in the registry?
The most recently registered devices listed for Edan Instruments, Inc. include Remote Event Marker 02.01.210095, Ultrasound Transducer US-SF, Ultrasound Transducer US-TF and Fetal & Maternal Module DECG-IF.