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Sign in to claim this brandGENDEX CORP.
US
Last updated May 24, 2026
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. The company’s devices are based in the United States and appear in regulatory databases such as the FDA’s 510(k) and UDI registries.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- gendex.com
- —
- —
- [email protected]
- Phone
- +18003238029
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 144575763
Catalogue (55)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Visualix Radiographic Image Detecting And Process | K925094 | FDA 510(k) | Class II | Active |
| Atc725, Atc525, And Ap300 | K922165 | FDA 510(k) | Class I | Active |
| Gx-Elevator | K894188 | FDA 510(k) | Class II | Active |
| Gx-Mobile X-Ray Unit | K873982 | FDA 510(k) | Class II | Active |
| Gendex Prince 30 Medical X-Ray Generator | K854499 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
GenDex Corp. has one FDA recall record initiated on 2014-08-12, which is marked as terminated. The recall was due to two failures of spring link components in the articulated arm assembly, where the spring links broke during the initial assembly process before the full load was applied.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 12, 2014 | Z-0009-2015 | — | 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. |