Data / Medical devices / Implant, Orbital, Extra-Ocular
Implant, Orbital, Extra-Ocular (HQX): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Implant, Orbital, Extra-Ocular (product code HQX, Class 2, 21 CFR 886.3340). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on January 8, 2003, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HQX
- Device class
- 2
- Regulation
- 886.3340
- Medical specialty
- Ophthalmic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| France | 1 |
| Mauritius | 1 |
| Netherlands | 1 |
Makers of Implant, Orbital, Extra-Ocular
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fci SAS | BESANCON Doubs, France | Manufacturer | 2 | September 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Manufacturer | 2 | September 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | ZUIDLAND Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer | 1 | January 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Microvision, Inc. | Seabrook, NH, United States | Manufacturer | 1 | January 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Mira, Inc. | Uxbridge, MA, United States | Manufacturer | 1 | June 5, 1996 | 0 | 0 | 0 | api.fda.gov |
Updated January 8, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.