Gendex Corp.
United StatesFDA applicant, unverified
Gendex Corp. is a medical device manufacturer, with 55 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 55
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 41
- FDA 510(k) 14
- Device classes
- FDA Class II 46
- FDA Class I 9
- FDA recalls
- Identifiers
- DUNS 144575763
At a glance
Market reach
- United States
- FDA recalls
What Gendex Corp. makes
The company manufactures intraoral dental imaging sensors and stationary digital x-ray systems designed for capturing high-resolution images of teeth and oral structures. It also produces single-use and non-sterile instrument drapes, cable covers for sensors, and multi-purpose digital medical cameras for clinical use. Software applications integrated with radiology information systems are part of its portfolio, enabling digital workflows in dental diagnostics.
These products are regulated under FDA classifications, including Class I and Class II devices, with some authorised through the 510(k) pathway and others listed under the Unique Device Identifier (UDI) system.
Catalogue
Search and filter all 55 devicesShowing 1-50 of 55
Company details
- DUNS number
- 144575763
- info@gendex.com
- Phone
- +18003238029
FDA recalls
FDA recall records list 1 recall initiated by GENDEX CORP., initiated on 2014-08-12. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 12 Aug 2014 Z-0009-2015 Class II Terminated Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
Full distribution text
- 12 Aug 2014 Z-0009-2015 Class II Terminated Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
Frequently asked questions
How many devices does GENDEX CORP. have in the registry?
The registry currently lists 55 devices for GENDEX CORP.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GENDEX CORP.'s devices?
Among its 50 most recently registered devices, GENDEX CORP. has devices listed in FDA 510(k) (9 devices) and FDA GUDID (41 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GENDEX CORP.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for GENDEX CORP.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for GENDEX CORP.?
FDA recall records list 1 recall initiated by GENDEX CORP., the most recent initiated on 12 Aug 2014. 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 GENDEX CORP. in the registry?
The most recently registered devices listed for GENDEX CORP. include KaVo GXS-700™ intraoral sensor 1.012.9159, Gendex GXS-700™ intraoral sensor 1.007.6200, KaVo GXS-700™ intraoral sensor 1.013.0511 and Gendex GXS-700™ intraoral sensor 0.822.4599.