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Newberg, United States
Oregon manufacturer of dental chairs, delivery systems, lights and dental furniture, made in the USA.
Accurate Surgical & Scientific Instruments
Westbury, United States
New York supplier of surgical instruments for many specialties, with offices on both US coasts.
Acumed
Hillsboro, United States
Oregon developer and manufacturer of orthopedic fracture fixation systems, including headless compression screws.
Aesculap
Center Valley, United States
Pennsylvania-based US arm of Aesculap providing surgical instruments, sterile container systems and implants.
Air Techniques
Melville, United States
New York manufacturer of dental mechanical systems, digital imaging and hygiene products since 1962.
American Dental Accessories
Minneapolis, United States
Minneapolis supplier of dental supplies and equipment repair parts with technical support, serving dentists since 1985.
American Diagnostic Corporation (ADC)
Hauppauge, United States
New York manufacturer of core diagnostic devices: stethoscopes, blood pressure instruments, thermometry and EENT.
Anthony Products
United States
US manufacturer and distributor of ENT surgical instruments, medical equipment and supplies since 1969.
Applied Medical
Rancho Santa Margarita, United States
California maker of minimally invasive surgery devices, including trocars, graspers, scissors and electrosurgical instruments.
Arthrosurface
West Bridgewater, United States
Massachusetts designer and manufacturer of motion-preserving joint replacement implants, founded in 2002.
Astura Medical
Irving, United States
Texas spinal device company formed in 2014 to develop, manufacture and distribute spinal fixation systems.
Bausch + Lomb
Bridgewater, United States
Eye health company supplying contact lenses, lens care, eye pharmaceuticals, intraocular lenses and eye surgery products.
Benco Dental
Pittston, United States
Pennsylvania dental distributor supplying equipment, supplies and practice services from regional distribution centers.
BioHorizons
Birmingham, United States
Birmingham, Alabama dental implant company whose titanium implants and abutments are manufactured in the U.S.
BIOLASE
Foothill Ranch, United States
California medical device company manufacturing and marketing proprietary dental laser systems.
BioMedtrix
Whippany, United States
New Jersey designer and manufacturer of veterinary orthopedic implants and instrumentation, founded in 1989.
Black & Black Surgical
Tucker, United States
Georgia supplier of plastic surgery instruments sourced from selected German and US manufacturers.
Boston Medical Products
Shrewsbury, United States
Massachusetts manufacturer of Montgomery brand ENT, respiratory and pulmonary specialty products, founded in 1980.
Boyd Industries
Clearwater, United States
Clearwater, Florida manufacturer of dental and surgical specialty chairs and equipment, founded in 1957.
Busse Hospital Disposables
Hauppauge, United States
New York manufacturer of single-use hospital disposables, procedure trays and private label products.
BVI Medical
Waltham, United States
Massachusetts-headquartered ophthalmic company manufacturing and distributing surgical devices for eye surgery in over 90 countries.
Case Medical
Bloomfield, United States
New Jersey manufacturer of instrument reprocessing products, including SteriTite reusable rigid sterilization container systems.
Chase Medical
Richardson, United States
Texas ISO 13485 certified manufacturer and worldwide distributor of devices for cardiac surgeons.
ChoiceSpine
Knoxville, United States
Knoxville, Tennessee spinal implant manufacturer offering pedicle screw, cervical and lateral systems and biologics.
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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.