Updated 23 October 2026
Surgical and endoscopy device distributors in the United States: 2,777 licensed establishments
The Bastion Hale Distributor Index lists 2,777 establishments in the United States whose registry records include surgery and endoscopy: 38 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 967 manufacturers' own import or sales entities, 1 regulatory representatives, and 1,771 manufacturers or exporters, out of 10,187 medical device establishments in the United States overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.
Top 20 independent surgery and endoscopy distributors
Independent distributors only, ranked by the lines each distributor carries for other manufacturers, then registrations held, then size.
- 1MERCEDES MEDICAL LLCLakewood Ranch, FL0 lines1 registrationsize 34.9
- 2FORA CARE INC.Moorpark, CA0 lines1 registrationsize 32.1
- 3Mazza Healthcare LLCLincolnshire, IL0 lines1 registrationsize 31.5
- 4MAXMORESPINESan Diego, CA0 lines1 registrationsize 31.2
- 5International Medical Lasers, Inc.Tualatin, OR0 lines1 registrationsize 30.8
- 6SEISA MEDICAL INCEl Paso, TX0 lines1 registrationsize 30.8
- 7Prime Med Shop LLCStafford, TX0 lines1 registrationsize 30.5
- 8HOME HEALTH US INCORPORATEDSarasota, FL0 lines1 registrationsize 29.4
- 9PRODIGY DIABETES CARE, LLCHuntersville, NC0 lines1 registrationsize 28.1
- 10GRAVITIQ LLCNew York, NY0 lines1 registrationsize 27.9
- 11JACK JACK LLCMiami, FL0 lines1 registrationsize 27.9
- 12PHARMA SUPPLY, INC.Wellington, FL0 lines1 registrationsize 27.0
- 13CARTESSA AESTHETICSMelville, NY0 lines1 registrationsize 26.7
- 14FOREO INCLas Vegas, NV0 lines1 registrationsize 26.3
- 15OUI LAB INC.City of Industry, CA0 lines1 registrationsize 25.5
- 16THORACENT LLCHuntington, NY0 lines1 registrationsize 25.5
- 17LetsGetChecked IncCity View Heights, OH0 lines1 registrationsize 25.1
- 18RIVIC, LLCMiami, FL0 lines1 registrationsize 25.1
- 19LIFE PRPDallas, TX0 lines1 registrationsize 24.1
- 20DELTA HI-TECH, INC.Fairfield, OH0 lines1 registrationsize 23.5
Include manufacturers, their own sales entities and regulatory representatives (2,739)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1Boston Scientific CorporationCoventry, RI0 lines520 registrationssize 80.6
- 2Covidien LLCNorth Haven, CT0 lines454 registrationssize 80.4
- 3ICU Medical, Inc.SOUTHINGTON, CT0 lines353 registrationssize 79.3
- 4Abbott MedicalPLANO, TX0 lines299 registrationssize 80.8
- 5ZIMMER, INC.WARSAW, IN0 lines249 registrationssize 80.6
- 6HOLOGIC, INC.Marlborough, MA0 lines245 registrationssize 74.6
- 7Conmed CorporationWESTBOROUGH, MA0 lines222 registrationssize 80.1
- 8Becton, DIckinson and CompanyCockeysville, MD0 lines204 registrationssize 81.4
- 9COOK, INCORPORATEDELLETTSVILLE, IN0 lines202 registrationssize 79.4
- 10MERIT MEDICAL SYSTEMS, INC.South Jordan, UT0 lines199 registrationssize 77.4
- 11Bausch & Lomb IncorporatedManchester, MO0 lines151 registrationssize 77.0
- 12Smith & Nephew, Inc.,MEMPHIS, TN0 lines137 registrationssize 78.8
- 13INSTRUMENTATION LABORATORY CO.Bedford, MA0 lines121 registrationssize 70.5
- 14HOWMEDICA OSTEONICS CORPORATIONMAHWAH, NJ0 lines114 registrationssize 78.8
- 15Teleflex Medical Inc.Morrisville, NC0 lines114 registrationssize 78.6
- 16ASPEN SURGICAL PRODUCTS, INC.Caledonia, MI0 lines113 registrationssize 75.3
- 17MICROPORT ORTHOPEDICS INC.Arlington, TN0 lines111 registrationssize 75.6
- 18MEDTRONIC SOFAMOR DANEK USA, INC.Memphis, TN0 lines109 registrationssize 77.0
- 19WELCH ALLYN, INC.Skaneateles Falls, NY0 lines105 registrationssize 74.0
- 20Avanos Medical, Inc.Alpharetta, GA0 lines104 registrationssize 70.4
Is your company in this list? Claim it free. No one can pay to be listed or ranked.
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 978 | 35% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 95 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 463 | 17% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 2,691 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 180 | 6% | 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 Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about surgery and endoscopy distributors in the United States
How many surgery and endoscopy distributors are there in the United States?
The Index counts 2,777 establishments in the United States with surgery and endoscopy in their registry record, of which 38 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 23 October 2026.
Who can hold a surgery and endoscopy 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 surgery and endoscopy 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 see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a surgery and endoscopy 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 surgery and endoscopy 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
Surgery and endoscopy in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 2,729 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 538 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 486 establishments, last seen 23 October 2026. Public register.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.