Updated 22 October 2026
Cardiovascular device distributors in the United States: 1,303 licensed establishments
The Bastion Hale Distributor Index lists 1,303 establishments in the United States whose registry records include cardiovascular: 17 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 452 manufacturers' own import or sales entities, 2 regulatory representatives, and 832 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.
Cardiovascular covers stents, catheters, pacemakers, heart valves, ECG and vascular access. Most products are implantable or high risk, which concentrates the segment in fewer, better capitalised importers. Reimbursement rules shape who can sell here more than in any other segment.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 452 | 35% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 50 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 359 | 28% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,267 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 159 | 12% | 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 17 independent cardiovascular distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | InfuSystem Inc. Lenexa, KS | Distributor Importer, Distributor | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 26 | 2 | 0 | 37.2 | 3/5 |
| 2 | JANT PHARMACAL CORP. ENCINO, CA | Distributor Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 59 | 1 | 0 | 33.7 | 3/5 |
| 3 | FORA CARE INC. Moorpark, CA | Distributor Importer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 43 | 1 | 0 | 32.1 | 3/5 |
| 4 | Mazza Healthcare LLC Lincolnshire, IL | Distributor Importer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 38 | 1 | 0 | 31.5 | 3/5 |
| 5 | SEISA MEDICAL INC El Paso, TX | Distributor Importer | Cardiovascular, General hospital and consumables, Ear, nose and throat +2 more | 19 | 1 | 1 | 30.8 | 4/5 |
| 6 | Prime Med Shop LLC Stafford, TX | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 31 | 1 | 0 | 30.5 | 3/5 |
| 7 | HOME HEALTH US INCORPORATED Sarasota, FL | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +1 more | 25 | 1 | 0 | 29.4 | 3/5 |
| 8 | PHARMA SUPPLY, INC. Wellington, FL | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 15 | 1 | 0 | 27.0 | 3/5 |
| 9 | Healthcare Logistics Systems CORAL SPRINGS, FL | Distributor Importer | Anaesthesia and respiratory, Cardiovascular | 11 | 1 | 0 | 25.5 | 3/5 |
| 10 | TRUMEDX LLC Shelton, CT | Distributor Importer | Cardiovascular, Patient monitoring and neurology | 11 | 1 | 0 | 25.5 | 3/5 |
| 11 | TELEEMG, LLC E Falmouth, MA | Distributor Importer | Cardiovascular, Ear, nose and throat, Patient monitoring and neurology | 5 | 1 | 0 | 22.0 | 3/5 |
| 12 | LERAISE HEALTH INTERNATIONAL LLC Dover, DE | Distributor Importer | Cardiovascular, In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 13 | CORVITEX CORPORATION Raleigh, NC | Distributor Importer | Cardiovascular | 1 | 1 | 0 | 16.5 | 3/5 |
| 14 | CRYON-X LLC Shelton, CT | Distributor Importer | Cardiovascular, Patient monitoring and neurology | 1 | 1 | 0 | 16.5 | 3/5 |
| 15 | NANO4IMAGING USA, LLC. Dublin, OH | Distributor Importer | Cardiovascular | 1 | 1 | 0 | 16.5 | 3/5 |
| 16 | TELLI HEALTH LLC Mcallen, TX | Distributor Importer | Cardiovascular | 1 | 1 | 0 | 16.5 | 3/5 |
| 17 | VOLTAS MEDICAL LLC Cottage Grove, MN | Distributor Importer | Cardiovascular | 1 | 1 | 0 | 16.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (1,286)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Siemens Healthcare Diagnostics, Inc. E Walpole, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 1527 | 894 | 0 | 80.6 | 3/5 |
| 2 | Boston Scientific Corporation Coventry, RI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1196 | 520 | 0 | 80.6 | 3/5 |
| 3 | Covidien LLC North Haven, CT | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 959 | 454 | 0 | 80.4 | 3/5 |
| 4 | ICU Medical, Inc. SOUTHINGTON, CT | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1023 | 353 | 0 | 79.3 | 3/5 |
| 5 | Abbott Medical PLANO, TX | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 619 | 299 | 1 | 80.8 | 4/5 |
| 6 | Conmed Corporation WESTBOROUGH, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 911 | 222 | 0 | 80.1 | 3/5 |
| 7 | Becton, DIckinson and Company Cockeysville, MD | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 693 | 204 | 1 | 81.4 | 4/5 |
| 8 | Microgenics Corporation Fremont, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Dental, Ear, nose and throat +1 more | 298 | 204 | 1 | 77.1 | 4/5 |
| 9 | COOK, INCORPORATED ELLETTSVILLE, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 202 | 0 | 79.4 | 3/5 |
| 10 | MERIT MEDICAL SYSTEMS, INC. South Jordan, UT | Maker's own entity Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 537 | 199 | 0 | 77.4 | 3/5 |
| 11 | INOVA DIAGNOSTICS, INC. SAN DIEGO, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics | 220 | 194 | 0 | 72.8 | 3/5 |
| 12 | RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC Murrysville, PA | Maker's own entity Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 619 | 183 | 0 | 70.7 | 3/5 |
| 13 | BECKMAN COULTER, INC. HIALEAH, FL | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +3 more | 750 | 151 | 0 | 77.8 | 3/5 |
| 14 | Bausch & Lomb Incorporated Manchester, MO | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 151 | 0 | 77.0 | 3/5 |
| 15 | Bio-Rad Laboratories, Inc. IRVINE, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +1 more | 373 | 143 | 0 | 74.0 | 3/5 |
| 16 | INSTRUMENTATION LABORATORY CO. Bedford, MA | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 177 | 121 | 0 | 70.5 | 3/5 |
| 17 | Teleflex Medical Inc. Morrisville, NC | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 114 | 1 | 78.6 | 4/5 |
| 18 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Maker's own entity Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 113 | 0 | 75.3 | 3/5 |
| 19 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 20 | WELCH ALLYN, INC. Skaneateles Falls, NY | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 373 | 105 | 1 | 74.0 | 4/5 |
Questions about cardiovascular distributors in the United States
How many cardiovascular distributors are there in the United States?
The Index counts 1,303 establishments in the United States with cardiovascular in their registry record, of which 17 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 22 October 2026.
Who can hold a cardiovascular 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 cardiovascular 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 cardiovascular 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 cardiovascular 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
Cardiovascular in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1,250 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 374 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 339 establishments, last seen 23 October 2026. Public register.
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.