NAICS 339112 Quarterly Industry Report
Surgical and Medical Instrument Manufacturing
Comprehensive industry research for valuation professionals, business owners, buyers, and lenders
NAICS Code: 339112Sector: 33Updated: Q1 2026
About This Report
Fair Market Value publishes this NAICS 339112 industry report using data from the U.S. Census Bureau[8] Economic Census, Bureau of Labor Statistics[7] employment surveys, and SBA size standard tables[9] for surgical and medical instrument production. Our research team monitors FDA regulatory changes, healthcare spending trends, and hospital procurement data through federal agencies and industry groups like AdvaMed. Quarterly updates reflect shifts in device regulation, reimbursement policy, and competitive dynamics affecting NAICS 339112 manufacturers.
Industry Snapshot
Key metrics for the surgical and medical instrument manufacturing industry.
Industry Definition & Overview
Surgical and Medical Instrument Manufacturing (NAICS 339112) encompasses establishments primarily engaged in manufacturing medical, surgical, ophthalmic, and veterinary instruments and apparatus, excluding electrotherapeutic, electromedical, and irradiation equipment. Products include syringes, hypodermic needles, anesthesia apparatus, blood transfusion equipment, catheters, surgical clamps, forceps, retractors, scalpels, and medical thermometers.
This sector operates under strict regulatory oversight from the Food and Drug Administration[5], which classifies devices into risk-based categories (Class I, II, or III) and requires premarket clearance or approval depending on the classification. Manufacturing facilities must register with the FDA and comply with Quality System Regulation (QSR) requirements covering design controls, production processes, and post-market surveillance. ISO 13485 certification serves as the international quality management standard for medical device producers.
The U.S. Census Bureau[6] places this code within Industry Group 3391 (Medical Equipment and Supplies Manufacturing). Data from the Bureau of Labor Statistics[7] shows the medical equipment manufacturing subsector employs hundreds of thousands of workers nationally. California, Massachusetts, Minnesota, Indiana, and New Jersey host the densest clusters of surgical instrument manufacturers, drawn by proximity to major hospital systems, research universities, and venture capital funding sources. Single-use disposable devices represent a growing share of production volume, driven by infection control priorities and hospital purchasing preferences.
What's Included in This Industry
- Manufacturing hypodermic syringes, needles, and injection devices
- Production of surgical hand instruments including scalpels, forceps, and retractors
- Manufacturing catheters, cannulas, and endoscopic instruments
- Production of anesthesia delivery apparatus and respiratory devices
- Manufacturing blood transfusion equipment and intravenous therapy devices
- Production of diagnostic instruments such as medical thermometers and stethoscopes
- Manufacturing ophthalmic surgical instruments and eye examination devices
- Production of veterinary surgical instruments and examination tools
- Manufacturing surgical clamps, hemostats, and wound closure devices
- Production of biopsy instruments and tissue sampling devices
NAICS Classification Hierarchy
| Level | Description | Code |
|---|---|---|
| Subsector | Miscellaneous Manufacturing | 339 |
| Industry Group | Medical Equipment and Supplies Manufacturing | 3391 |
| NAICS Industry | Medical Equipment and Supplies Manufacturing | 33911 |
| National Industry | Surgical and Medical Instrument Manufacturing | 339112 |
Related NAICS Codes
| Code | Description | Relationship |
|---|---|---|
| 339113 | Surgical Appliance and Supplies Manufacturing | Surgical appliance and supplies manufacturing produces orthopedic devices, prosthetics, and surgical dressings rather than surgical instruments and apparatus |
| 339114 | Dental Equipment and Supplies Manufacturing | Dental equipment and supplies manufacturing produces specialized instruments for dental procedures, separate from general surgical instrument production |
| 334510 | Electromedical and Electrotherapeutic Apparatus Manufacturing | Electromedical and electrotherapeutic apparatus manufacturing covers electronic diagnostic and treatment devices excluded from the surgical instrument classification |
| 334517 | Irradiation Apparatus Manufacturing | Irradiation apparatus manufacturing produces X-ray machines and radiation therapy equipment distinct from mechanical surgical instruments |
| 339115 | Ophthalmic Goods Manufacturing | Ophthalmic goods manufacturing produces corrective lenses and eyewear rather than the ophthalmic surgical instruments covered by this code |
| 325411 | Medicinal and Botanical Manufacturing | Medicinal and botanical manufacturing produces pharmaceutical compounds and biological products used alongside surgical instruments in clinical settings |
Geographic Concentration
Top states by share of national establishments.
| # | State | % Est. | Total Est. |
|---|---|---|---|
| 1 | California | 20.1% | 261 |
| 2 | Minnesota | 6.1% | 79 |
| 3 | Massachusetts | 5.2% | 68 |
| 4 | Florida | 5.2% | 67 |
| 5 | Texas | 4.7% | 61 |
| 6 | Pennsylvania | 4.3% | 56 |
| 7 | New York | 3.9% | 50 |
| 8 | Illinois | 3.8% | 49 |
| 9 | Indiana | 3.7% | 48 |
| 10 | Tennessee | 2.7% | 35 |
% Of Establishments
0%
20%
Source: County Business Patterns, U.S. Census Bureau[3]
SBA Lending Summary
216
Total SBA Loans
$151.6M
Total Loan Volume
$702K
Average Loan Size
9 yrs
Average Loan Term
10.61%
Average Interest Rate
1,920
Jobs Supported
Source: SBA 7(a) Program Data, U.S. Small Business Administration — FY 2025[4]
Key Insight: The SBA size standard[9] for NAICS 339112 is 1,000 employees. Several large multinational device companies operate in this space, but the industry also supports thousands of small and mid-size manufacturers. Small business designation opens access to federal procurement set-asides through the Department of Veterans Affairs[10] and Department of Defense medical supply programs. SBA 7(a) loans[11] fund working capital, regulatory compliance costs, and production equipment. The 504 program[12] supports cleanroom construction and specialized manufacturing equipment investments.
Top SBA Lenders
| # | Lender | Loans | Volume | Avg Loan |
|---|---|---|---|---|
| 1 | Columbia Bank | 8 | $40.0M | $5.0M |
| 2 | U.S. Bank, National Association | 8 | $27.4M | $3.4M |
| 3 | Regions Bank | 16 | $18.7M | $1.2M |
| 4 | Legacy Bank | 16 | $14.4M | $900K |
| 5 | Stearns Bank National Association | 16 | $10.8M | $675K |
Frequently Asked Questions
Common questions about this industry.
What types of businesses fall under NAICS 339112?
NAICS 339112 covers manufacturers producing surgical instruments, medical apparatus, ophthalmic instruments, and veterinary instruments. Businesses range from large multinational device companies with global distribution networks to specialized firms producing niche instruments for particular surgical specialties. Single-use disposable device manufacturers and reusable surgical instrument producers both qualify. The Census Bureau[6] specifies that electromedical and irradiation apparatus are classified separately.
How is NAICS 339112 structured within the classification system?
NAICS 339112 belongs to Sector 33 (Manufacturing), Subsector 339 (Miscellaneous Manufacturing), Industry Group 3391 (Medical Equipment and Supplies Manufacturing). It sits alongside 339113 (surgical appliances and supplies), 339114 (dental equipment), 339115 (ophthalmic goods), and 339116[13] (dental laboratories). Electronic medical devices fall under Subsector 334 rather than this code.
What is the SBA size standard for surgical instrument manufacturing?
The SBA size standard[9] for NAICS 339112 is 1,000 employees. This high threshold reflects the presence of several large device companies, but thousands of smaller manufacturers also operate in this sector. Small business status opens access to VA and DoD medical procurement set-asides, which represent a substantial share of government device purchasing.
What NAICS codes are closely related to 339112?
Directly related codes include 339113 (surgical appliances and supplies), 339114 (dental equipment), and 334510[14] (electromedical apparatus). NAICS 334517 covers irradiation apparatus like X-ray machines. Ophthalmic goods (339115) covers lenses rather than instruments. Pharmaceutical manufacturing (325411) produces drugs used alongside surgical instruments in clinical procedures.
What industries are closely connected to surgical instrument manufacturing?
Hospitals (NAICS 622110) and ambulatory surgical centers (621493) serve as primary end-user markets. Medical device wholesalers (423450) manage distribution. Research firms (541714) drive product innovation. The Bureau of Labor Statistics[7] tracks employment for the medical equipment manufacturing subsector. Group purchasing organizations (GPOs) aggregate hospital buying power and negotiate supply contracts that influence manufacturer pricing and market access.
What specific activities are included in NAICS 339112?
Included activities cover manufacturing syringes, hypodermic needles, catheters, anesthesia apparatus, blood transfusion equipment, surgical clamps, forceps, retractors, scalpels, medical thermometers, stethoscopes, biopsy instruments, and ophthalmic surgical tools. Veterinary surgical instruments also qualify. Per the Census Bureau[6], the code excludes electromedical apparatus (334510), irradiation equipment (334517), and surgical appliances like orthopedic devices (339113).
Can surgical instrument manufacturers qualify for SBA loans?
Yes. Manufacturers under 1,000 employees qualify for SBA lending programs[15]. The 7(a) program finances working capital, regulatory compliance activities, and production equipment. Industry 504 program[12] supports cleanroom facility construction and precision manufacturing equipment like laser cutting systems and automated assembly lines. SBIR and STTR grant programs also fund early-stage medical device innovation.
Where is surgical instrument manufacturing concentrated in the U.S.?
Manufacturing clusters align with major medical research and healthcare centers. California leads in establishment count, driven by the San Francisco Bay Area and Southern California device corridors. Massachusetts benefits from proximity to Boston-area teaching hospitals. Minnesota's Twin Cities region hosts a dense medtech cluster anchored by large device companies. Indiana, New Jersey, and Pennsylvania also support notable production concentrations. Proximity to hospital systems, research universities, and FDA regulatory expertise influences location decisions for device manufacturers.
Sources & References
Government datasets and editorial sources used in this report.
- [1]U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages bls.gov
- [2]U.S. Census Bureau, Economic Census census.gov
- [3]U.S. Census Bureau, County Business Patterns census.gov
- [4]U.S. Small Business Administration, SBA 7(a) Loan Program Data data.sba.gov
- [5]Food and Drug Administration fda.gov
- [6]U.S. Census Bureau census.gov
- [7]Bureau of Labor Statistics bls.gov
- [8]U.S. Census Bureau data.census.gov
- [9]SBA size standard tables sba.gov
- [10]Department of Veterans Affairs va.gov
- [11]SBA 7(a) loans sba.gov
- [12]504 program sba.gov
- [13]339116 census.gov
- [14]334510 census.gov
- [15]SBA lending programs sba.gov
Disclaimer
This publication has been prepared by Fair Market Value (“Fair Market Value”) for informational purposes only. It is provided on an “as-is” and “as available” basis. Fair Market Value makes no representations or warranties, express or implied, regarding the merchantability, fitness for a particular purpose, completeness, or accuracy of the data or information contained herein. This publication is not intended to be, and should not be construed as, professional financial, legal, tax, or investment advice. Users should consult with qualified professionals before making any financial or business decisions based on the information presented.
To the extent permitted by law, Fair Market Value disclaims all liability for loss or damage, direct and indirect, suffered or incurred by any person resulting from the use of, or reliance upon, the data in this publication.
Copyright © 2026 Fair Market Value. All rights reserved. All data, information, articles, graphs, and content contained in this publication are copyrighted works and Fair Market Value hereby reserves all rights. No part of this publication may be copied, reproduced, republished, uploaded to a third party, or distributed without the prior written permission of Fair Market Value.