Updated 25 October 2026

Medical device distributors in North America: 12,955 licensed establishments in 2 markets

925 independent medical device distributors and importers are licensed in 2 markets in North America (the United States and Canada), out of 12,955 registered medical device companies, from US FDA (openFDA), Health Canada and MHRA UK, updated 25 October 2026. Each market links to its own page with the ranked list, who holds the registration and a free CSV.

12,955establishments

2markets

925independent distributors

1,726registration holders

Medical device distributors in North America by country

Every market in North America with a licensed establishment in the Index, the most independent distributors first. Importers and holders (registration holders, authorised representatives and sponsors) count every establishment with that role, independent or not. Total counts every licensed establishment.

Market	Independents	Importers	Holders	Total
Canada	763	1,703	545	2,768
United States	162 a minimum: the US FDA registration database lists no distributors	2,859	1,181	10,187

Top 20 medical device distributors in North America

Independent distributors only, ranked by the other manufacturers' lines each carries or represents in the registries, then registrations held, then size score. Not a ranking by revenue: the registries publish none.

1
TRIBE MEDICAL GROUPLondon Ontario, Canada
0 lines2 registrationsSize score 48 of 100
2
INNOPEX LIMITEDToronto Ontario, Canada
0 lines2 registrationsSize score 46 of 100
3
K.M. Medical & Trading IncNorth York Ontario, Canada
0 lines2 registrationsSize score 43 of 100
4
InfuSystem Inc.Lenexa, United States
0 lines2 registrationsSize score 37 of 100
5
INNOVARXI LTD.Concord Ontario, Canada
0 lines2 registrationsSize score 29 of 100
6
Ems Surplus Canada Inc.Sombra Ontario, Canada
0 lines2 registrationsSize score 26 of 100
7
PROBO MEDICAL, INC.Fishers, United States
0 lines2 registrationsSize score 26 of 100
8
SIARON MEDICAL LTDVancouver British Columbia, Canada
0 lines2 registrationsSize score 26 of 100
9
Rowland Emergency Vehicle Products Inc.Etobicoke Ontario, Canada
0 lines2 registrationsSize score 26 of 100
10
ATFC LIMITEDOshawa Ontario, Canada
0 lines2 registrationsSize score 24 of 100
11
Celllab International, LlcWyomissing, United States
0 lines2 registrationsSize score 24 of 100
12
MICRO DIRECT, INC.Lewiston, United States
0 lines2 registrationsSize score 24 of 100
13
SONDERCARE INC.London Ontario, Canada
0 lines2 registrationsSize score 24 of 100
14
Patheon Inc.Whitby, Canada
0 lines2 registrationsSize score 15 of 100
15
MERCEDES MEDICAL LLCLakewood Ranch, United States
0 lines1 registrationSize score 35 of 100
16
JANT PHARMACAL CORP.Encino, United States
0 lines1 registrationSize score 34 of 100
17
FORA CARE INC.Moorpark, United States
0 lines1 registrationSize score 32 of 100
18
HANSAmed Limited DBA CitagenixMississauga Ontario, Canada
0 lines1 registrationSize score 32 of 100
19
Mazza Healthcare LLCLincolnshire, United States
0 lines1 registrationSize score 32 of 100
20
United Imaging Healthcare North America, IncHouston, United States
0 lines1 registrationSize score 31 of 100

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Segments in North America

Establishments in North America whose registry records include each segment (total), the independent distributors among them, and the country pages for the segment; a company can appear in several segments. Each segment links to its page for every market.

Segment	Total	Independents	Pages
General hospital and consumables	3,187	35	2
Surgery and endoscopy	2,947	44	2
Patient monitoring and neurology	2,774	34	2
Gastroenterology, urology and OB/GYN	1,636	31	2
Orthopaedics, spine and trauma	1,528	7	2
In-vitro diagnostics	1,458	25	2
Dental	1,446	17	2
Cardiovascular	1,418	21	2
Anaesthesia and respiratory	1,150	13	2
Ophthalmic	1,079	10	2
Ear, nose and throat	980	8	2
Aesthetics, dermatology and lasers	189	8	2

Medical device registration in North America, country by country

One line per registration rule, for the markets where a public source confirms it. Each country page has the full rule.

Canada: Health Canada licence for class II to IV with an MDSAP certificate; no reliance on CE or FDA decisions. Importers and distributors need an establishment licence. Who holds registrations there: the list. Sources: Health Canada, Guidance on how to complete the application for a new medical device....
United States: FDA clearance or approval is the market authorisation, plus establishment registration and listing; CE has no standing. Sources: US FDA, Overview of device regulation.

Who should hold the registration, and how a transfer works

General information, not legal advice. Local law varies; take local counsel.

Meeting distributors in person? WHX Miami and the other shows in the trade show guide

Next steps

How to find a medical device distributor in a new country Medical device trade shows for finding distributors Which country first? Sequencing medical device market entry

All guides

Questions about medical device distributors in North America

How many medical device distributors are there in North America?

The Index lists 12,955 licensed medical device establishments in 2 markets in North America, of which 925 are independent distributors or importers (a channel role and no manufacturing of their own). The US FDA registration database does not list distributors, so the count is a minimum in the markets it covers. The records come from US FDA (openFDA), Health Canada and MHRA UK, Index build of 25 October 2026.

Which countries in North America have the most medical device distributors?

By independent distributors in the Index: Canada (763) and the United States (162). By all licensed establishments, the largest markets are the United States (10,187) and Canada (2,768). Index build of 25 October 2026.

Is there a list of medical device distributors in North America?

Yes. This page lists every market in North America with its counts, and each country page lists its independent distributors, ranked, with a free CSV of every registered medical device company in that market. Company records only, no contact people.

Who can hold a medical device registration in North America?

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. In Canada the device licence (MDALL) is held by the manufacturer, while importers and distributors need a Medical Device Establishment Licence (MDEL). The manufacturer keeps the product registration; the distributor's MDEL is its own and transfers nothing to it. General information, not legal advice. Local law varies; take local counsel.

Other regions

Europe 6,571 GCC 911 Africa 4,015 Latin America 1,339 Asia Pacific 603

Every market by region

Sources

US FDA Establishment Registration and Device Listing, openFDA bulk download: 10,071 establishments, last seen 23 October 2026. US government work, public domain.
Health Canada MDALL active licence listing and MDEL establishment licence listing: 4,106 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
UK MHRA Public Access Registration Database (PARD): 1,744 establishments, last seen 23 October 2026. Public register.

Index build 25 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.