Medical Instrument Suppliers & Distributors in the United States
Suppliers and distributors of medical instruments with an address in the United States that do not describe themselves as manufacturers. Each business type is quoted from the company’s own website.
Companies whose address is in the United States and whose own website describes them as a supplier or distributor (not a manufacturer). Companies that only export to or serve the United States are not included.
Suppliers & Distributors in the United States
American Dental Accessories
Minneapolis, United States
Minneapolis supplier of dental supplies and equipment repair parts with technical support, serving dentists since 1985.
Benco Dental
Pittston, United States
Pennsylvania dental distributor supplying equipment, supplies and practice services from regional distribution centers.
Black & Black Surgical
Tucker, United States
Georgia supplier of plastic surgery instruments sourced from selected German and US manufacturers.
Dental City
Green Bay, United States
Green Bay, Wisconsin dental supply distributor of over 400 brands, serving practices nationwide since 1993.
Dentalaire Products
Irvine, United States
California supplier of veterinary dentistry products, instruments and equipment since 1988.
Dynarex
Montvale, United States
New Jersey medical supply company with US warehouses and distributor partners across the Americas, operating since 1967.
Ellis Instruments
Madison, United States
New Jersey supplier of ophthalmic surgical instruments and products, serving customers since 1995.
Healthmark Industries
Fraser, United States
Michigan provider of sterile processing products such as instrument trays, containers, cleaning verification tests and packaging; a Getinge company.
Henry Schein
Melville, United States
New York-based worldwide distributor of dental and medical supplies, equipment and corporate-brand products.
Invotec International
Jacksonville, United States
Jacksonville, Florida medical supplier of instruments, optics, implants and supplies for ENT, plastic and cosmetic surgery.
Life Instrument Corporation
Braintree, United States
Massachusetts supplier of spinal, orthopedic and neurosurgical instruments for bone and soft tissue, founded in 1991.
Marina Medical Instruments
Davie, United States
Davie, Florida designer and supplier of German-made instrument systems for rhinoplasty, plastic and ENT surgery.
Millennium Surgical
Bala Cynwyd, United States
Pennsylvania supplier of a broad range of surgical instruments to hospitals and surgical facilities.
Mountainside Medical Equipment
Marcy, United States
Family-owned New York distributor of medical supplies and equipment sourced directly from manufacturers, established in 2002.
MWI Animal Health
Boise, United States
Boise, Idaho animal health distributor supplying veterinarians and producers with products and technology solutions.
MYCO Medical
Apex, United States
North Carolina supplier of surgical blades and scalpels, needles and other single-use medical devices sourced through a global manufacturer network.
Practicon
Greenville, United States
North Carolina supplier of dental supplies, tools and infection control products, serving dental professionals since 1982.
Roboz Surgical Instrument Co.
Gaithersburg, United States
Maryland-based designer and supplier of fine surgical instruments for healthcare and research, with a catalog of over 1000 products.
Safco Dental Supply
United States
US dental supply distributor selling brand-name dental products as an authorized distributor for its manufacturers.
Salvin Dental Specialties
Charlotte, United States
Charlotte, North Carolina supplier of surgical instruments, biomaterials and pharmaceuticals for implant dentistry.
Scott’s Dental Supply
Gig Harbor, United States
Washington State dental supply distributor offering brand-name products and its own Scott's Select line, founded in 2002.
Sontec Instruments
Centennial, United States
Colorado supplier of surgical instruments, knife and blade handles and instrument storage products.
Surgical Direct
Orange City, United States
Florida supplier of surgical equipment and instruments from major manufacturers, including laparoscopic instruments, with service.
Surgical Tools
Bedford, United States
Virginia supplier of German-manufactured surgical instruments, medical tools and supplies, established in 1995.
Business types in the United States
Cities
Regulation in the United States
Regulator: U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)
FDA regulates devices by class (I-III). All need registration/listing and general controls; many also need 510(k) clearance, De Novo or PMA before sale.
From the sourced FDA CDRH entry, checked 29 October 2026. General information, not legal advice. Requirements for United States · All medical certifications
Frequently asked questions
Do manual surgical instruments need a 510(k) to be sold in the United States?
Many do not. Under 21 CFR 878.4800, manual surgical instruments for general use (nonpowered, hand-held or hand-manipulated reusable or disposable instruments such as forceps, clamps, scalpels and retractors) are Class I and exempt from 510(k), subject to the limitations in 21 CFR 878.9.
"Exempt" does not mean unregulated. The establishment must still register and list, and labeling, UDI and medical device reporting rules apply. Instruments for specialty uses (for example dental, ophthalmic or orthopedic) are classified in other regulations and may differ, and listing a device as exempt is not proof that it is. Check the classification regulation and product code for each item. See the medical certifications page.
How can I check a supplier’s FDA status for a specific instrument?
Ask the supplier for four items, then check them against FDA's public databases:
- the establishment's FDA registration and owner/operator number;
- the device listing, with its product code;
- the classification regulation (for example 21 CFR 878.4800 for many manual instruments) and whether the device is exempt;
- the 510(k), De Novo or PMA number where premarket review was required.
Remember that registration is not approval, and listing an exempt device does not prove the exemption applies. FDA does not issue registration certificates. Use the United States country page to shortlist suppliers, and see the medical certifications page.
What are a US importer’s obligations for medical devices?
Initial importers are among the establishment types FDA lists as needing to register; FDA's who-must-register table sets out the details. Importers also have medical device reporting duties: report deaths and serious injuries to FDA and the manufacturer, and malfunctions to the manufacturer, within 30 calendar days, electronically.
An importer does not need its own 510(k) if the foreign manufacturer holds one for the device. If an importer relabels or repackages, it takes on additional obligations as a relabeler or repackager. When choosing a US importer or distributor from the United States directory, ask how it handles complaint files, reporting and recalls for the brands it carries.
What does a foreign manufacturer need before selling surgical instruments in the United States?
In outline, under FDA rules:
- Find the device's classification regulation and product code (many manual instruments fall under 21 CFR 878.4800, Class I and 510(k)-exempt, but specialty instruments may differ).
- Obtain 510(k) clearance, De Novo or PMA if the device type is not exempt.
- Register the foreign establishment with FDA, renew it each year between 1 October and 31 December, pay the annual fee and designate a US agent with a US physical address.
- List each device.
- Meet the QMSR, labeling (21 CFR 801), UDI and medical device reporting rules unless exempted.
Fees change each fiscal year. Browse US-based companies on the United States country page and see the medical certifications page.