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Sign in to claim this brandGYNEX CORPORATION
US
Last updated September 17, 2026
What GYNEX CORPORATION makes
Gynex Corporation manufactures reusable medical devices for gynecological and surgical procedures, including vaginal speculums, soft-tissue manipulation forceps, open-surgery biopsy forceps, electrocautery electrodes, uterine fibroid hooks, colposcopes, endometrial biopsy curettes, and fixed-diameter cervical dilators. Their product line also includes loop electrodes for cervical ablation procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 6631 Browning Dr, North Richland Hills, TX, 76180
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3001238683
- DUNS Number
- 012997685
Catalogue (495)
Page 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gynex | 2818 | FDA UDI | Class I | Active |
| Specula, Single-Use | SSU2448 | FDA UDI | Class II | Active |
| Gynex | TT037 | FDA UDI | Class I | Active |
| Gynex | 4008.5 | FDA UDI | Class I | Active |
| Gynex | 1006 | FDA UDI | Class I | Active |
| Gynex | 1010 | FDA UDI | Class I | Active |
| Gynex | 4005.2.5 | FDA UDI | Class I | Active |
| Gynex | CSU3900-6 | FDA UDI | Class I | Active |
| Gynex | CSU3900-0 | FDA UDI | Class I | Active |
| Gynex | 3594 | FDA UDI | Class I | Active |
| Gynex | 4334 | FDA UDI | Class I | Active |
| Gynex | TT595-36 | FDA UDI | Class I | Active |
| Gynex | 1065 | FDA UDI | Class I | Active |
| Patient Dispercive Pad | 21-809 | FDA UDI | Class II | Active |
| Gynex | 1021 | FDA UDI | Class I | Active |
| Gynex | 29-300 | FDA UDI | Class I | Active |
| Gynex | 4250 | FDA UDI | Class I | Active |
| Gynex | 3572 | FDA UDI | Class I | Active |
| Gynex | 3680-20 | FDA UDI | Class I | Active |
| Gynex | 4223 | FDA UDI | Class I | Active |
| Gynex | 3592 | FDA UDI | Class I | Active |
| Gynex | 2459 | FDA UDI | Class I | Active |
| Gynex | 1060 | FDA UDI | Class I | Active |
| Gynex | 4008.6 | FDA UDI | Class I | Active |
| Gynex | 2801 | FDA UDI | Class I | Active |
| Gynex | 29-800 | FDA UDI | Class I | Active |
| Gynex | 3135 | FDA UDI | Class II | Active |
| Gynex | 1075 | FDA UDI | Class I | Active |
| Gynex | 2780 | FDA UDI | Class I | Active |
| Gynex | 4601 | FDA UDI | Class I | Active |
| Gynex | CSU3900-1 | FDA UDI | Class I | Active |
| Gynex | S001 | FDA UDI | Class I | Active |
| Galileo Colposcope, Direct Access | 400DA-T | FDA UDI | Class II | Active |
| Gynex | TA010 | FDA UDI | Class I | Active |
| Gynex | 2879 | FDA UDI | Class I | Active |
| Gynex | 1070 | FDA UDI | Class I | Active |
| Gynex | 4008.3 | FDA UDI | Class I | Active |
| Gynex | 29010 | FDA UDI | Class I | Active |
| Gynex | 10-200 | FDA UDI | Class II | Active |
| H-Series Loop Electrodes | 13-1010 | FDA UDI | Class II | Active |
| Gynex | LE055 | FDA UDI | Class I | Active |
| Gynex | 4202 | FDA UDI | Class I | Active |
| Gynex | 1025 | FDA UDI | Class I | Active |
| Gynex | 1303 | FDA UDI | Class I | Active |
| Gynex | 2885 | FDA UDI | Class I | Active |
| Gynex | TT590-30 | FDA UDI | Class I | Active |
| Gynex | 3304 | FDA UDI | Class I | Active |
| Galileo Colposcope, Direct Access | 200LDA-T | FDA UDI | Class II | Active |
| Radius Loop Electrodes | 12-1007 | FDA UDI | Class II | Active |
| Gynex | 3680-23 | FDA UDI | Class I | Active |
Related Companies
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No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
Gynex Corporation has one FDA recall record initiated on 2012-09-06, which is marked as terminated. The recall was due to an assembly issue where the wrong electrical connector pin was attached to the cord, making the device incompatible with its port and thus unusable.
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 |
|---|---|---|---|---|
| Sep 6, 2012 | Z-0008-2013 | — | terminated | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. |