Updated 22 October 2026
Medical device distributors in the United States: 9,881 licensed establishments
The Bastion Hale Distributor Index lists 9,881 medical device establishments registered with an address in the United States: 3,097 with a channel role (importer, distributor, wholesaler or authorised representative), 734 registration holders without a channel role, and 6,050 registered as manufacturer or exporter only. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 2,859 | 29% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 389 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 1,181 | 12% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 9,483 | 96% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 475 | 5% | 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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Abbott Medical PLANO, TX | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 619 | 238 | 1 | 78.4 | 4/5 |
| 2 | Boston Scientific Corporation Coventry, RI | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1196 | 411 | 0 | 78.2 | 3/5 |
| 3 | ZIMMER, INC. WARSAW, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 1316 | 240 | 0 | 78.2 | 3/5 |
| 4 | 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 |
| 5 | Conmed Corporation WESTBOROUGH, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 911 | 201 | 0 | 77.7 | 3/5 |
| 6 | 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 |
| 7 | ICU Medical, Inc. SOUTHINGTON, CT | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1023 | 272 | 0 | 76.9 | 3/5 |
| 8 | Siemens Healthcare Diagnostics, Inc. E Walpole, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 1527 | 139 | 0 | 76.5 | 3/5 |
| 9 | HOWMEDICA OSTEONICS CORPORATION MAHWAH, NJ | Channel Importer, Registration holder, Manufacturer | Ear, nose and throat, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 901 | 104 | 1 | 76.0 | 4/5 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | SMITH & NEPHEW, INC. MEMPHIS, TN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +5 more | 1710 | 97 | 0 | 74.8 | 3/5 |
| 14 | WRIGHT MEDICAL TECHNOLOGY, INC. Arlington, TN | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 685 | 76 | 1 | 74.4 | 4/5 |
| 15 | 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 |
| 16 | MERIT MEDICAL SYSTEMS, INC. South Jordan, UT | Channel Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 537 | 165 | 0 | 74.1 | 3/5 |
| 17 | Microgenics Corporation Fremont, CA | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Dental, Ear, nose and throat +1 more | 298 | 173 | 1 | 74.0 | 4/5 |
| 18 | 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 |
| 19 | Kerr Corporation ORANGE, CA | Channel Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +3 more | 504 | 92 | 1 | 73.7 | 4/5 |
| 20 | BECKMAN COULTER, INC. HIALEAH, FL | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +3 more | 750 | 84 | 0 | 72.7 | 3/5 |
Questions about medical device distributors in the United States
How many medical device distributors are there in the United States?
The Index counts 9,881 medical device establishments registered in the United States, of which 3,097 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in the United States?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and the United States to see the counts for your segment and reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a distributor in the United States?
An establishment is a company that appears in a public regulatory registry with an address in the United States, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Segment pages for the United States
Related markets in North America
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 9,431 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1,646 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.