Updated 22 October 2026
Ophthalmic device distributors in the United States: 989 licensed establishments
The Bastion Hale Distributor Index lists 989 establishments in the United States whose registry records include ophthalmic: 498 with a channel role (importer, distributor, wholesaler or authorised representative), 65 registration holders without a channel role, and 426 registered as manufacturer or exporter only, out of 9,881 medical device establishments in the United States overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Ophthalmic covers intraocular lenses, diagnostic and surgical equipment, contact lenses and vision care. Buyers are eye hospitals, day surgery centres and optical retail, each with its own distributors. Intraocular lenses are a tender-driven, high-volume line in most public systems.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 489 | 49% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 26 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 127 | 13% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 968 | 98% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 67 | 7% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in the United States
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
Top 20 ophthalmic establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Covidien LLC North Haven, CT | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 959 | 338 | 0 | 78.0 | 3/5 |
| 2 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 3 | COOK, INCORPORATED ELLETTSVILLE, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 150 | 0 | 75.6 | 3/5 |
| 4 | Teleflex Medical Inc. Morrisville, NC | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 99 | 1 | 75.5 | 4/5 |
| 5 | Becton, DIckinson and Company Cockeysville, MD | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 693 | 89 | 1 | 75.2 | 4/5 |
| 6 | Bausch & Lomb Incorporated Manchester, MO | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 139 | 0 | 74.2 | 3/5 |
| 7 | DEPUY ORTHOPAEDICS, INC. RAYNHAM, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 773 | 58 | 1 | 73.7 | 4/5 |
| 8 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Channel Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 96 | 0 | 72.2 | 3/5 |
| 9 | KLS-Martin L.P. Jacksonville, FL | Channel Importer, Distributor, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +7 more | 561 | 52 | 1 | 71.6 | 4/5 |
| 10 | WELCH ALLYN, INC. Skaneateles Falls, NY | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 373 | 104 | 1 | 71.5 | 4/5 |
| 11 | DeRoyal Industries, Inc. NEW TAZEWELL, TN | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 1991 | 46 | 0 | 70.1 | 3/5 |
| 12 | STERIS CORPORATION Breckenridge Hills, MO | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 591 | 40 | 0 | 68.0 | 3/5 |
| 13 | KATENA PRODUCTS, INC. Randolph, NJ | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 403 | 44 | 1 | 67.9 | 4/5 |
| 14 | COOPERSURGICAL, INC. Trumbull, CT | Channel Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 250 | 76 | 0 | 66.6 | 3/5 |
| 15 | INTEGRA LIFESCIENCES CORPORATION PLAINSBORO, NJ | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 945 | 17 | 0 | 66.5 | 3/5 |
| 16 | PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 199 | 64 | 1 | 66.1 | 4/5 |
| 17 | Beaver-Visitec International, Inc. Little Silver, NJ | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +5 more | 160 | 68 | 0 | 62.6 | 3/5 |
| 18 | CYNOSURE, LLC Westford, MA | Channel Importer, Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +4 more | 197 | 31 | 0 | 62.3 | 3/5 |
| 19 | RELIANCE ORTHODONTIC PRODUCTS, INC. ITASCA, IL | Channel Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Ophthalmic | 123 | 32 | 0 | 59.1 | 3/5 |
| 20 | BUSSE HOSPITAL DISPOSABLES HAUPPAUGE, NY | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 92 | 22 | 1 | 58.6 | 4/5 |
Questions about ophthalmic distributors in the United States
How many ophthalmic distributors are there in the United States?
The Index counts 989 establishments in the United States with ophthalmic in their registry record, of which 498 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a ophthalmic device registration in the United States?
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
How do I find a ophthalmic distributor in the United States?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United States to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a ophthalmic distributor in the United States?
A company that appears in a public regulatory registry with an address in the United States and whose linked device listings fall in the ophthalmic segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in the United States
Ophthalmic in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 982 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 152 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.