NAICS UNIVERSITY · Free research for insurance agents
Surgical and Medical Instrument Manufacturing
NAICS 339112 · United States · 2022 edition
This U.S. industry comprises establishments primarily engaged in manufacturing medical, surgical, ophthalmic, and veterinary instruments and apparatus (except electrotherapeutic, electromedical, and irradiation apparatus). Examples of products made by these establishments are syringes, hypodermic needles, anesthesia apparatus, blood transfusion equipment, catheters, surgical clamps, and medical thermometers.
Start the review with products liability.
For Surgical and Medical Instrument Manufacturing, the saved research highlights products liability, product recall, completed operations. Confirm how these arise in the actual operation, what controls are used and whether additional services change the proposed coverage.
Questions to ask
- What specific product lines are manufactured, and what are their FDA device classifications?
- Has the company experienced any FDA enforcement actions, warning letters, or recalls?
- Where are products distributed — domestic only, or internationally?
- Do any products incorporate software, electronics, or implantable components?
- What quality management certifications are in place (e.g., ISO 13485)?
- What are the per-unit values and annual production volumes of primary product lines?
- For Surgical and Medical Instrument Manufacturing, what should the underwriter know about fda warning letters, consent decrees, or prior mandatory recall actions?
- For Surgical and Medical Instrument Manufacturing, what should the underwriter know about class iii device designation or implantable products with life-sustaining function?
Activities described by this code
Other activities to examine
- Manufacturing electromedical and electrotherapeutic apparatus: 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
- Manufacturing irradiation apparatus: 334517 — Irradiation Apparatus Manufacturing
- Manufacturing surgical (except dental) and orthopedic appliances or specialized hospital furniture (e.g., hospital beds, operating tables): 339113 — Surgical Appliance and Supplies Manufacturing
- Manufacturing dental equipment, dental supplies, dental laboratory apparatus, and dental laboratory furniture: 339114 — Dental Equipment and Supplies Manufacturing
- Manufacturing thermometers (except medical): 334519 — Other Measuring and Controlling Device Manufacturing;
- Manufacturing ophthalmic goods: 339115 — Ophthalmic Goods Manufacturing
Census classification reference
For educational purposes only. AI-generated insurance research and automated logic can contain errors. Independently verify classification and coverage decisions.
Compare another operationInsurance operations research — draft
Surgical and medical instrument manufacturers design and produce precision tools and apparatus used in clinical, surgical, and veterinary settings — including syringes, catheters, surgical clamps, anesthesia equipment, and diagnostic instruments. Operations typically involve precision machining, assembly, sterilization processes, and rigorous quality control in a controlled manufacturing environment. Products are sold to hospitals, surgical centers, distributors, and occasionally directly to practitioners.
Questions to investigate
- What specific product lines are manufactured, and what are their FDA device classifications?
- Has the company experienced any FDA enforcement actions, warning letters, or recalls?
- Where are products distributed — domestic only, or internationally?
- Do any products incorporate software, electronics, or implantable components?
This insurance research was generated in April 2026. It has not received a complete human review. The October 12, 2026 audit checked codes and titles only, not descriptions or coverage assertions.