Updated 22 October 2026
Gastroenterology and urology device distributors in the United States: 1,524 licensed establishments
The Bastion Hale Distributor Index lists 1,524 establishments in the United States whose registry records include gastroenterology, urology and ob/gyn: 589 with a channel role (importer, distributor, wholesaler or authorised representative), 100 registration holders without a channel role, and 835 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.
Gastroenterology, urology and obstetrics covers flexible endoscopy accessories, lithotripsy, dialysis, catheters and women's health devices. Dialysis consumables bring large recurring volumes and a few dominant players. The rest of the segment is spread across many mid-sized importers.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 573 | 38% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 59 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 240 | 16% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,477 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 123 | 8% | 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 gastroenterology, urology and ob/gyn 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 | 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 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | C.R. BARD, INC. COVINGTON, GA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 769 | 58 | 0 | 71.1 | 3/5 |
| 19 | MICROPORT ORTHOPEDICS INC. Arlington, TN | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 645 | 59 | 0 | 70.3 | 3/5 |
| 20 | 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 |
Questions about gastroenterology, urology and ob/gyn distributors in the United States
How many gastroenterology, urology and ob/gyn distributors are there in the United States?
The Index counts 1,524 establishments in the United States with gastroenterology, urology and ob/gyn in their registry record, of which 589 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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
Gastroenterology, urology and OB/GYN in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1,519 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 284 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.