Data / Medical devices / Eye, Artificial, Non-Custom
Eye, Artificial, Non-Custom (HQH): 24 FDA-registered makers in 5 countries
24 establishments in 5 countries are registered with the FDA to make Eye, Artificial, Non-Custom (product code HQH, Class 1, 21 CFR 886.3200). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 26, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HQH
- Device class
- 1
- Regulation
- 886.3200
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 16 |
| India | 5 |
| United Kingdom | 1 |
| Japan | 1 |
| Mexico | 1 |
Makers of Eye, Artificial, Non-Custom
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 |
|---|---|---|---|---|---|---|---|---|
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cantor Barnard Ltd | Northamptonshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eye Prosthetics Of Wisconsin, Inc. | Brookfield, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indo-German Surgical Corporation | Mumbai Maharashtra, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iscon Surgicals, Ltd. | JODHPUR Rajasthan, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jardon Eye Prosthetics, Inc. | Southfield, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JUNE R.R. NICHOLS, OCULARIST LTD. d/b/a OCULARISTS Ltd | Des Plaines, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legrand Assoc. | Broomall, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lights' Prosthetic Eyes, Inc. | Peoria, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Sioux Falls LLC | Sioux Falls, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Woodbury LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Rochester, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Eau Claire, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocular Instruments, Inc. | Bellevue, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocular Prosthetics, Inc. | Los Angeles, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul Instruments (india) | CALCUTTA West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Soper Brothers & Associates | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steven R. Young Ocularist, Inc. | Oakland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Eye Concern, Inc. | Mesa, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thompson Ocular Prosthetics, Inc. | Olmos Park, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 26, 1995. 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.