Minxray, Inc.
United StatesFDA applicant, unverified FDA FEI 1418960
Minxray, Inc. is a medical device manufacturer, with 44 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 2 FDA recalls as of 13 Nov 2026.
- Devices
- 44
- Registrations
- FDA
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 26
- FDA 510(k) 18
- Device classes
- FDA Class II 44
- FDA recalls
- Identifiers
- FDA FEI 1418960
- DUNS 042071001
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 44 devicesCompany details
- FDA FEI number
- 1418960
- DUNS number
- 042071001
- Address
- 3611 COMMERCIAL AVE., NORTHBROOK, IL, 60062
- service@minxray.com
- Phone
- 800-221-2245
FDA recalls
2004
- 29 Jun 2004 Z-0985-04 Unclassified (pre-2012) Terminated The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
- 29 Jun 2004 Z-0986-04 Unclassified (pre-2012) Terminated The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
Frequently asked questions
How many devices does Minxray, Inc. have in the registry?
The registry currently lists 44 devices for Minxray, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Minxray, Inc.'s devices?
Among its 44 most recently registered devices, Minxray, Inc. has devices listed in FDA 510(k) (18 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Minxray, Inc.'s devices fall under?
Among its 44 most recently registered devices, the classes recorded for Minxray, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Minxray, Inc.?
FDA recall records list 2 recalls initiated by Minxray, Inc., the most recent initiated on 29 Jun 2004. 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 Minxray, Inc. in the registry?
The most recently registered devices listed for Minxray, Inc. include MinXray CMDR.PE.100.S, MinXray CMDR.PE.1202.R, MinXray CMDR.PE.100.R and MinXray CMDR.TW.1202.R.