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Surgical Instrument Manufacturers

Last updated: January 2026

This directory lists 108 surgical instrument manufacturers across the United States, from precision fine instrument specialists to high-volume orthopedic tool fabricators.

Buyers in this category are typically solving critical problems related to scaling production, ensuring regulatory compliance, and maintaining stringent quality. They require partners who can handle complex processes like deep-hole drilling for cannulated instruments, achieve specific surface finishes through electropolishing, and provide robust material traceability to meet ISO 13485 standards. The right manufacturer minimizes risk in product commercialization and supports regulatory submissions.

Suppliers in this space vary significantly, ranging from small, agile workshops specializing in custom, intricate prototypes and short runs of surgical tools, to large-scale operations with extensive capabilities for high-volume production of standard instruments, reusable device components, or complex robotic surgical systems. Some focus on specific material types like titanium or specialized stainless steels (e.g., ASTM F899), while others offer broad expertise across various instrument families, including general surgery, neurosurgery, or orthopedics.

To engage effectively, buyers should come prepared with detailed CAD models, material specifications, required surface finishes (e.g., satin, mirror), and clear functional requirements. Suppliers expect a comprehensive understanding of regulatory pathways (e.g., FDA 510(k), CE mark for MDR) and the target market. Be ready to discuss Design for Manufacturability (DFM) implications, inspection criteria, and your traceability requirements for raw materials and process steps, especially concerning crucial post-processing like passivation.

108 companies·72 emails·95 phones

Company Directory

108 companies nationwide

Westbury, NY

Based in Westbury, NY, Accurate Surgical & Scientific Instruments provides a broad selection of high-quality surgical instruments. They offer electrosurgical instruments, bipolar forceps, needle holders, scissors, and microvascular clamps. The company serves various specialties, including microsurgery, hand surgery, bone and soft tissue, urology, and infertility procedures.

San Marcos, CA

ACI Medical is a US-based contract manufacturing and engineering firm specializing in medical devices. They provide custom molding and manufacturing services, known for their problem-solving capabilities and on-time order production, supporting other manufacturers in the medical industry.

Based in Center Valley, PA, Aesculap, Inc. manufactures a comprehensive range of high-quality surgical instruments. The company designs, develops, and produces surgical tools for various medical specialties, utilizing modern, owned, and operated factories globally, including significant manufacturing facilities within the United States.

Houston, TX

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer of medical devices and components. They provide vertically integrated design and manufacturing services from their state-of-the-art facility, helping partners shorten time to market. The company delivers quality Made in USA products.

Based in Beverly, MA, American Surgical Company manufactures a range of single-use medical devices. Their offerings include neurosurgical patties and strips, disposable non-stick bipolar forceps, and specialized ophthalmology and ENT products. All devices are proudly manufactured in the U.S.A. using 100% wind-powered electricity.

Cincinnati, OH

Based in Cincinnati, OH, Ameri Surgical Instruments Inc. provides FDA-registered and ISO 13485 certified surgical instrument sets. They specialize in Class I medical devices, offering a range of instruments for procedures such as cleft lip repair, abdominoplasty, and blepharoplasty.

Applied Medical develops and provides breakthrough technologies and solutions for Minimally Invasive and General Surgery, as well as Bariatric and Cardiac procedures. This medical device company operates with a vertically integrated business model to enhance clinical care globally.

Cleveland, OH

Based in Cleveland, OH, Applied Medical Technology, Inc. designs, engineers, and manufactures medical devices. The company provides a vast surgical line of products, including disposable retractor frames, smoke and fluid evacuators. With over 40 years of experience, AMT produces American-made surgical supplies.

Minneapolis, MN

Aprios provides custom manufacturing services, including precision injection molding and additive manufacturing, for medical device manufacturers. Operating ISO 13485 certified clean room facilities, they offer design for manufacturing, tooling, and comprehensive quality management. Aprios delivers speed, quality, and precision from concept to completion.

ARCH Medical Solutions Corp. is an ISO 13485-certified manufacturer producing surgical implants and instruments for the medical industry. Operating FDA-registered facilities nationwide, they leverage precision CNC manufacturing for orthopedic, spine, dental, surgical robotics, and general medical devices. They also offer MedTorque silicone-handled instruments.

ARCH Global Precision is a contract manufacturer with advanced precision-machining capabilities. Their Medical Solutions group specializes in producing orthopedic and dental implants and instruments. They also manufacture components and subassemblies for robotic-assisted surgical equipment and medical devices, utilizing modern CNC technologies.

Rosemont, IL

Based in Rosemont, IL, Avalign Technologies, Inc. manufactures precision-machined implants and surgical instruments for orthopedic, spine, and trauma applications. The company offers capabilities such as porous coatings, cutting instruments, and custom delivery systems. They provide both additive and subtractive manufacturing expertise.

Santa Barbara, CA

Bentec Medical, based in Santa Barbara, CA, specializes in custom silicone fabrication and contract manufacturing for medical device OEMs. They design and produce FDA/CE approved silicone medical devices used across various surgical fields, offering comprehensive services including design, prototyping, assembly, sterilization, and packaging.

Houston, TX

Based in Houston, TX, Biotex Inc. is an ISO-certified, FDA-registered medical device CDMO with over 25 years of experience. The company provides comprehensive services for the design, development, and manufacturing of life-changing medical devices, including surgical instruments, for various patient care needs.

Savannah, GA

Based in Savannah, GA, Brasseler USA Surgical manufactures high-quality orthopedic cutting accessories. Their precision instruments, including telescoping burs, saw blades, and twist drills, are designed and manufactured in the USA using surgical grade materials. The company provides cost-effective solutions compatible with major OEM power systems.

Houston, TX

Based in Houston, TX, Centerline Manufacturing, LTD. is an American contract manufacturer specializing in custom CNC machining. They produce close-tolerance parts and components for medical, aerospace, and defense applications. The company operates with AS9100 and ISO 9001:2015 quality control systems to ensure precision manufacturing.

Boulder, CO

Corza Ophthalmology is a global manufacturer specializing in surgical instruments for the ophthalmology sector. With manufacturing capabilities across seven locations worldwide, including facilities in the United States, the company provides essential tools for ophthalmic procedures.

Fort Worth, TX

Based in Fort Worth, TX, DesignPlex Biomedical LLC offers contract manufacturing, prototyping, and design development for FDA Class II and III medical devices. They leverage CNC milling, 3D printing, laser cutting, and cleanroom workstations. The company provides ISO 13485-compliant manufacturing, ensuring precision and quality for complex medical products.

Disposable Instrument manufactures custom stainless steel surgical components for the medical device industry in the United States. Their offerings include wound drainage trocars, fixation pins, K-wires, tunnelers, guide pins, obturators, handles, points, and ends, all produced to customer specifications and industry regulations.

Paso Robles, CA

Based in Paso Robles, CA, Eagle Medical Inc. provides contract manufacturing, packaging, and sterilization solutions for medical products. The company offers process and sterility validation studies, environmental controls, and new product introduction services, certified to ISO 13485:2016 requirements.

Thousand Oaks, CA

Based in Thousand Oaks, CA, ECA Medical specializes in manufacturing single-use, Surgery-Ready™ surgical instruments and procedure kits. They focus on solutions for cardio, neuro, ortho, and spine procedures, designed to enhance safety, reduce infection risks, and improve efficiency while lowering costs for healthcare providers.

Bartlett, TN

Engineered Medical Systems, LLC provides full-service contract manufacturing for complex medical devices, including surgical instruments and implants. Based in Bartlett, TN, they offer prototype design, verification, validation, and production. The company utilizes state-of-the-art facilities and advanced technology to ensure precision.

Kennesaw, GA

Based in Kennesaw, GA, Fehling Surgical Instruments, Inc. manufactures and distributes high-grade surgical instruments for Cardiac, Thoracic, Neuro, and Spine procedures. With thirty years experience, they offer innovative, FDA 510(k) certified instruments, including tools for minimally invasive mitral valve repair.

La Habra, CA

Based in La Habra, CA, HDA Technology specializes in creating and building medical devices. The company provides manufacturing services for clients across the country, focusing on developing and producing a range of medical device solutions for various applications.

Irvine, CA

Based in Irvine, CA, Integrated Endoscopy develops and manufactures advanced single-use rigid endoscopes. The company's NUVIS Single-Use Arthroscope provides high-definition optics for arthroscopic procedures. They focus on revolutionizing wireless arthroscopic technology, offering sterile, reliable, and cord-free surgical instruments.

Savannah, GA

Based in Savannah, GA, Innomed, Inc. specializes in providing a comprehensive range of orthopedic surgical instruments and implants. Their product lines support various surgical procedures including hip, knee, shoulder and elbow, small bone, trauma, and spine surgery, catering to general orthopedic needs.

Sunnyvale, CA

Based in Sunnyvale, CA, Intuitive Surgical manufactures advanced robotic surgical instruments for platforms like Da Vinci and Ion. These systems enable minimally invasive procedures, including single-incision surgery and robotic bronchoscopy. The company provides specialized multi-jointed instruments designed for precise and transformative surgical approaches.

Cleveland, OH

Kapp Surgical Instrument Inc. designs, prototypes, and manufactures custom stainless steel surgical instruments and implants. Based in Cleveland, OH, the company offers products like heart vent catheters, surgical retractors, and upper extremity implant systems. They provide custom instrument design services and worldwide sales and distribution.

Chula Vista, CA

Kirwan Surgical Products, LLC, based in Chula Vista, CA, specializes in creating and developing advanced bipolar and monopolar products. The company manufactures instruments tailored for demanding microsurgical specialties, including ophthalmology, ear, nose and throat, plastic and reconstructive surgery, and orthopaedic surgery.

Camarillo, CA

Based in Camarillo, CA, Laube Technology specializes in providing medical-grade titanium engineered to ensure precise cuts and extend the lifespan of surgical tools. They offer specialized materials for various medical applications.

Louisville, CO

Based in Louisville, CO, Lenox MacLaren manufactures surgical instruments for medical facilities, specializing in spine and neurosurgery. They offer a range of their own branded products, including curettes, osteotomes, and elevators, designed for precise surgical applications.

Life Instrument Corporation manufactures high-quality surgical instruments for orthopedic and neurosurgeons. They provide a wide array of catalog instruments, including spinal, orthopedic, and neurosurgical tools. Custom engineering and design services are also provided, featuring innovative radiolucent retractors and specialized micro surgical sets.

San Diego, CA

Based in San Diego, CA, LivsMed develops groundbreaking technology for minimally invasive surgery. The company manufactures ArtiSential laparoscopic instruments and tools, including forceps, clip appliers, dissectors, and needle holders. LivsMed also produces ArtiSeal, an articulating, double-jointed vessel sealer, designed to simplify robotic surgical procedures.

Hollywood, FL

Madison Ortho manufactures and supplies a diverse portfolio of orthopedic implants, instruments, and prostheses. The company focuses on creating precise and safe orthopedic medical devices to support surgeons in providing effective treatments, shorter hospitalizations, and improved patient quality of life.

Marshall Manufacturing Company specializes in the production of surgical instruments. The company utilizes various machining processes, including advanced precision 3D machining, to create complex medical device components. They provide high-quality manufacturing solutions tailored for the demanding requirements of the healthcare and medical device industries.

Based in Stoughton, MA, Marver Med is a contract manufacturer specializing in CNC Swiss-Screw Machine made parts for medical device products. They produce micro-precision and conventional parts, including surgical instruments and medical implants, meeting rigorous tolerances. The company is ISO 13485 certified.

Dallas, TX

Based in Dallas, TX, MedCAD manufactures custom surgical solutions, including patient-matched implants, personalized titanium plates, and precise surgical guides. Utilizing advanced 3D printing and multi-axis milling, they create devices for CMF reconstruction, orthognathic, and lower extremity surgeries, optimizing patient outcomes.

Microline Surgical manufactures innovative reposable laparoscopic instrument systems. Their products feature a re-usable handpiece designed to be fitted with various interchangeable components, offering value and flexibility for surgical procedures. The company specializes in advanced surgical tools for the medical industry.

MSI Precision Specialty Instruments specializes in manufacturing precision tools for neurosurgery, including brain spatulas, dissectors, elevators, probes, rongeurs, scissors, and retractors. Based in Phoenixville, PA, the company provides a comprehensive range of specialty instruments for medical professionals in the surgical field.

Dayton, OH

Norwood Medical, based in Dayton, OH, specializes in precision medical device manufacturing. They provide post-processing and assembly services for critical markets like cardiovascular, minimally invasive surgery, orthopedics, and robotic-assisted surgery technologies. The company has nearly a century of experience.

Flint, MI

Omega Surgical Instruments is a global manufacturer and supplier of replacement surgical drill bits, saw blades, and burs. Based in Flint, MI, the company offers cost-effective solutions for hospitals, specializing in essential components for various surgical applications including handpiece brands, twist drills, and cast cutters.

Santee, CA

Based in Santee, CA, Pathway Medtech is a U.S.-based contract manufacturer and developer specializing in medical devices. They provide single-source solutions for commercializing products, offering expertise in design, engineering, regulatory, and manufacturing. The company assists medtech innovators throughout the product lifecycle.

Houston, TX

Phasor Health manufactures and assembles FDA-cleared, single-use disposable power drills and cranial access kits in its US facilities. The company focuses on safety, offering anti-plunging technology for neurosurgical applications and providing sterile, ready-to-use solutions for hospitals.

PMT Corporation specializes in the development, manufacture, and distribution of high-quality instruments and devices for neurosurgery and orthopedics. The company produces specialized products, including those for Subdural Epilepsy, serving the medical industry.

Angola, IN

Precision Edge Surgical Products, based in Sault Ste. Marie, MI, specializes in manufacturing orthopedic cutting tools and instruments. They provide development support and production services for OEM partners, focusing on high-quality, complex surgical products. With over 35 years of experience, the company ensures confidence in tools for surgeons.

Oceanside, CA

Precision One Medical specializes in manufacturing precision products for the global dental implant market. Based in Oceanside, CA, the company focuses on delivering high-quality surgical instruments and components, emphasizing efficient process streams and strategic throughput to support dental professionals worldwide.

Roseville, CA

Based in Roseville, CA, PRIDE Industries is an ISO 9001 and 13485-registered facility, fully compliant with FDA regulations. The company provides competitive business services, indicating expertise in contract manufacturing for medical devices, including surgical instruments. Its mission is to create employment for people with disabilities.

Bland, MO

Based in Bland, MO, Roberson Machine Company provides precision CNC machining, milling, turning, wire EDM, and 3D printing services. The company specializes in medical device manufacturing, offering prototype to production capabilities for various industries using materials like stainless steel and aluminum.

San Diego, CA

Based in San Diego, CA, Roboz Surgical Instrument Co. designs and develops a comprehensive range of surgical instruments and related products. The company provides specialty instruments, ultrasonic instrument cleaners, and magnifying loupes, primarily serving the healthcare industry.

Fremont, CA

Sonic Manufacturing Technologies specializes in the design and manufacture of electronic assemblies for medical devices. Adhering to ISO 13485-2016 standards, the company ensures high-quality production for critical medical applications. Based in Fremont, CA, they provide specialized manufacturing services for electronic components essential to the medical device industry.

Centennial, CO

Based in Centennial, CO, Sontec Instruments, Inc. provides a diverse range of surgical instruments. They offer specialized sets for procedures such as penile implant, arthroscopy, veterinary, and spinal surgeries. The company also supplies individual instruments, including various forceps and knife handles for medical professionals.

Ventura, CA

Based in Ventura, CA, Stark Surgical Instruments designs and manufactures high-quality surgical instruments and medical devices. With over 15 years of industry experience, the company focuses on precision, performance, and patient safety. They offer customization services, leveraging cutting-edge technology and rigorous testing to meet regulatory standards.

Kalamazoo, MI

Based in Kalamazoo, MI, Sterling Industries is a contract development and manufacturing organization (CDMO) specializing in medical devices and their components. They provide end-to-end services, from design engineering and fabrication to assembly, packaging, and regulatory compliance.

Cincinnati, OH

Strand Products, Inc. specializes in high-tolerance custom mechanical wire, wire rope, and cable assemblies for medical devices. They provide surgical component and subassembly services within ISO Class 7 cleanrooms, working with materials like Nitinol, Stainless Steel, and Titanium. Capabilities include laser welding, crimping, and testing.

Grand Rapids, MI

Based in Grand Rapids, MI, Surge Cardiovascular is an ISO 13485 certified medical device manufacturer. The company specializes in creating innovative products for demanding cardiac care professionals, enhancing the surgical suite with advanced solutions. They are dedicated to producing high-quality devices for the medical industry.

Mokena, IL

Based in Mokena, IL, Synergy Surgical manufactures a range of reusable surgical instruments for the medical industry. Their product line includes essential tools such as forceps, hemostats, scissors, clamps, and retractors, focusing on meticulous design and purpose.

Rosemont, IL

Tegra Medical provides contract manufacturing services for precision medical devices, specializing in sharp tips and implant solutions for orthopedics, spine, and trauma applications. With manufacturing facilities in the United States, the company partners with OEMs for end-to-end product development and production of finished surgical instruments and components.

Addison, IL

Based in Addison, IL, Tritone is an ISO 13485:2016 certified surgical instrument manufacturer, established 1996. They provide precision machining, contract manufacturing, and supply chain integration for medical OEMs. Specializing in high-quality medical devices and instruments from German Forged Stainless Material, Tritone ensures FDA compliance for custom and generic needs.

San Ramon, CA

Based in San Ramon, CA, TTI Medical specializes in manufacturing sterilizable, high-quality minimally invasive surgical instruments. Their Accu-Surg® product line offers cost-effective instruments made from durable stainless steel for various medical applications.

UFP Technologies provides design, development, engineering, and manufacturing services primarily for medical devices and sterile packaging. The company specializes in single-use and single patient devices, working with foams, films, and plastics. Its facilities, including one in El Paso, TX, are ISO 13485 certified for medical device manufacturing.

Dayton, MN

Based in Dayton, MN, Unity Precision Manufacturing specializes in precision contract manufacturing for orthopedic implants and surgical instruments. Their capabilities encompass CNC machining, turning, wire EDM, laser marking, and contract assembly. Serving the medical and commercial sectors, they maintain ISO 9001, 13485, and FDA registrations for quality assurance.

Lenexa, KS

Based in Lenexa, KS, Vantage Medtech is an FDA registered and ISO13485 certified contract manufacturer specializing in medical devices. They provide comprehensive MedTech solutions, ensuring high-quality production of devices like surgical instruments through rigorous testing and robust processes.

Based in Waltham, MA, Vicarious Surgical designs and manufactures an advanced robotic system for minimally invasive surgery. Their single-port technology maximizes abdominal access, visualization, and precision control of specialized robotic instruments and disposables, enabling smaller incisions for surgeons.

Houston, TX

Based in Houston, TX, Wexler Surgical manufactures titanium and stainless steel surgical instruments. They provide custom MICS sets, single-use products, and instrument care solutions. Their specialized offerings include forceps for VATS and PTE procedures, Uniport VATS instruments, and Potts Scissors, leveraging advanced materials like Nitinol.

Based in Warminster, PA, Acrotec Medtech is a medical device contract manufacturing partner. They specialize in producing high-precision custom surgical cutting and shaft instruments for minimally invasive bone and tissue applications. The company offers efficient and bespoke medical device components, providing innovative manufacturing solutions.

BVI Medical US manufactures and distributes surgical devices dedicated to ophthalmology. Its product portfolio includes consumables, equipment, and intraocular lenses. Supporting procedures for cataract, glaucoma, and vitreoretinal conditions, the global company serves healthcare professionals in the United States and over 90 countries.

Abbott develops and manufactures advanced medical device technologies and solutions for treating cardiovascular conditions. The company provides life-changing devices and therapies for healthcare professionals, integral to various surgical and interventional procedures. Its offerings support patient care by supplying specialized cardiovascular instruments and related solutions.

Palo Alto, CA

Based in Palo Alto, CA, Fine Science Tools (FST) manufactures a comprehensive range of microsurgical instruments under its FST® brand. Their product line includes scissors, forceps, scalpels, needles, and clamps for scientific and medical applications. Established in 1974, FST distributes its quality instruments globally.

Integra LifeSciences develops and manufactures a broad portfolio of surgical instruments and solutions. The company specializes in neurosurgery, offering products for dural access, cerebral spinal fluid management, and neuro-critical care. They also provide advanced instrumentation for wound reconstruction, plastic and reconstructive surgery, and an ultrasonic surgical aspirator system.

Pristine Surgical develops and manufactures 4K single-use surgical arthroscopes and endoscopes. Their innovative Summit™ product aims to simplify endoscopy, enhancing efficiency, consistency, and safety in surgical suites. The company offers its visualization technology via a subscription model.

Weston, FL

Stryker is a medical technology company with extensive global operations, impacting millions of patients annually. The company develops and manufactures a comprehensive range of medical devices and solutions. It provides various surgical instruments and related technologies for healthcare customers worldwide.

Tecomet provides innovative medical manufacturing solutions, specializing in high-precision surgical instruments for hip, knee, and shoulder reconstruction. The company partners with leading medical companies, offering expertise from design prototyping to full-scale production, committed to delivering unparalleled manufacturing excellence and quality.

Cincinnati, OH

Based in Cincinnati, OH, ACE Medical Company specializes in advanced machining and manufacturing of orthopedic surgical instruments and implants. They adhere to the highest global quality standards, compliant with FDA regulations and certified to ISO 13485, serving the medical device industry.

Fremont, CA

Based in Fremont, CA, A&D Precision Inc. is an ISO 13485 certified contract manufacturer specializing in medical device manufacturing. They offer precision machining, clean room assembly, and validation services, with experience in complex products like surgical robots and blood analyzers.

Queensbury, NY

AngioDynamics is a medical technology company headquartered in Queensbury, NY, specializing in the research, development, and manufacture of innovative medical devices. They produce minimally invasive surgical instruments, catheters, and ablation systems, providing solutions for patient care in interventional oncology, vascular access, and peripheral vascular disease.

Mason, OH

AtriCure, based in Mason, OH, is a leading medical device manufacturer specializing in innovative surgical instruments. The company produces a reusable valve platform designed to provide maximum surgical exposure and flexibility for both mitral and aortic valve procedures, supporting advanced cardiovascular surgical techniques.

Based in Sterling, MA, BMP Medical specializes in custom medical plastics manufacturing for OEMs. They provide injection molding, injection blow molding, and precision medical assembly services. Offering contract services, they support design, development, and process validation for medical device components and IVD devices.

East Windsor, NJ

Based in East Windsor, NJ, Carnegie Surgical LLC provides custom manufacturing and OEM/private label solutions for a wide range of surgical instruments. Their modern facility uses advanced CNC machinery and skilled technicians to offer services like milling, turning, laser welding, and passivation for medical device companies.

Chantilly, VA

Cipher Surgical, based in Chantilly, VA, specializes in providing innovative tools for laparoscopic surgery. The company offers a range of surgical instruments, including its signature OpClear® Lens Cleaning Device. This specialized device is designed to assist surgeons by ensuring clear visualization during procedures.

CONMED manufactures a comprehensive portfolio of surgical instruments for laparoscopic and robotic surgery, including specimen bags, uterine manipulators, and access devices. The company empowers healthcare providers globally by offering innovative solutions that positively affect patient outcomes.

San Antonio, TX

Based in San Antonio, TX, Cox Manufacturing Company offers made-to-spec precision machined medical parts. They specialize in ultra-precision and micro machining, capable of high-volume orders. The company works with various metals and plastics, including stainless steel and titanium, providing reliable quality components for the medical industry.

Morgan Hill, CA

Based in Morgan Hill, CA, DUKE Empirical specializes in custom manufacturing medical device tubing and catheter components. The company provides precision medical extrusion services, offering complete, turnkey design and manufacturing solutions for medical devices, including VERGO® Steerable Access Sheaths.

Fremont, CA

Based in Fremont, CA, Evolve Manufacturing specializes in the contract manufacturing of complex medical and life sciences devices and instruments. Operating from a 75,000 sq ft facility in Silicon Valley, the company provides comprehensive manufacturing services for advanced healthcare technologies.

Hartland, WI

Fathom Manufacturing provides integrated contract manufacturing services, specializing in metal CNC machining and advanced engineering. They have decades of experience in the medical sector, producing surgical tools, medical device enclosures, syringes, and orthopedic implants. The company also serves aerospace & defense, automation & robotics, semiconductor, and automotive industries.

Grafton, WI

Gauthier Biomedical manufactures high-quality instruments for spine, trauma, hip, shoulder, knee, ankle, and small bone surgical applications. Based in Grafton, WI, the company develops complete branded instrument systems with ergonomic designs and innovative features, collaborating on unique custom product development.

Austin, TX

Based in Austin, TX, Genesys Spine is a medical device company established in 2009. They specialize in advanced spinal fusion technologies, including 3D printed cervical standalone systems and sacroiliac joint fusion devices. The company emphasizes engineering excellence and surgeon efficiency in its product development.

Costa Mesa, CA

JG Plastics Group LLC specializes in assembling medical devices, including surgical instruments, diagnostic equipment, and drug delivery systems. Based in Costa Mesa, CA, they provide expert injection molding and mold making for demanding, close tolerance parts, utilizing scientific molding principles and decades of experience.

White Plains, NY

Based in White Plains, NY, LASCHAL® Surgical Instruments is a manufacturer specializing in innovative dental instruments. The company reinvented the market with its SONIC STEEL® instruments, designed to reliably deliver great patient outcomes for the dental and surgical industries.

Olympus Surgical Technologies America manufactures advanced surgical devices and innovative applications. The company develops solutions for diverse medical specialties including urology, gynecology, and ear, nose, and throat procedures. They also provide technologies for respiratory and energy-related surgical interventions, aiming to enhance patient care.

Anaheim, CA

Moseys Production Machinists operates a state-of-the-art medical device machine shop, specializing in the creation of complex medical parts. They employ precision machining processes to ensure components meet or exceed rigorous industry standards. Located in Anaheim, CA, they are a direct manufacturer for the medical sector.

Buffalo, NY

Based in Buffalo, NY, Nissha Medical Technologies specializes in the design and manufacturing of single-use medical technologies and medical surgical consumables. The company distributes high-quality products directly to hospitals and clinical centers of excellence. Nissha Medical Technologies also offers private label options for many of its consumable medical products.

Holt, MI

Based in Holt, MI, Orchid Orthopedic Solutions specializes in manufacturing medical devices and components, primarily for the trauma, spine, and dental markets. Capabilities include Swiss-style turning, packaging, anodizing, and cleaning, providing solutions for orthopedic implant procedures.

Pierceton, IN

Paragon Medical, based in Pierceton, IN, specializes in the design, development, and advanced manufacturing of highly engineered surgical instruments, implantable components, and sterilization cases and trays. They provide comprehensive custom manufacturing solutions for the medical device industry, ensuring precision and quality.

Redwood City, CA

Petersen Precision, based in Redwood City, CA, manufactures high-precision metal parts for medical device OEMs. Specializing in complex designs with tight tolerances, their capabilities include fine blanking, CNC machining, and precision grinding. This ISO 9001/AS9100 certified company offers turnkey support from prototype to volume production.

Warsaw, IN

Based in Warsaw, IN, Precision Medical Technologies is an ISO 13485:2016 Certified contract manufacturer specializing in orthopedic and minimally invasive surgical devices and instrumentation. They provide end-to-end manufacturing solutions, including design for manufacturability, prototyping, high-volume production, and sterile packaging, for OEM partners.

St. Louis, MO

SIM Surgical is a contract medical manufacturing company based in St. Louis, MO. They specialize in producing German quality surgical instruments and medical implants. The company utilizes advanced manufacturing capabilities including 3D printing, 5 Axis CNC Milling, Turning, and EDM machining.

Based in West Chester, PA, Sklar Corporation provides a comprehensive selection of surgical instruments, offering five grades from German stainless steel to economical options. The company supports healthcare professionals with instrument care and repair services, ensuring product integrity and surgical success.

Lexington, KY

Based in Lexington, KY, Stephens Instruments manufactures over 1,000 high-grade stainless steel and titanium surgical instruments. Specializing in ophthalmic products, they provide both single-use and reusable options for the ophthalmic community. The company has served customers for over 40 years, with instruments backed by a lifetime warranty.

Vista, CA

Based in Vista, CA, Surgistar manufactures single-use ophthalmic, ENT, surgical, and dental instruments. With over 20 years of experience, the company produces and packages all its medical devices in its California facility. Surgistar provides specialized surgical instruments to various healthcare sectors.

Alpharetta, GA

Based in Alpharetta, GA, Sutter Medical Technologies USA is a subsidiary of Sutter Medizintechnik Germany, specializing in advanced electrosurgical medical devices. The company manufactures precision instruments and systems, including 4 MHz radiofrequency generators and bipolar forceps, supporting medical professionals with surgical innovations for cutting, coagulation, and tissue preservation.

Spicewood, TX

Based in Spicewood, TX, American Valmark Manufacturing provides precision medical machining services. They fabricate fixtures and tooling for the medical industry, utilizing advanced CNC milling, turning, grinding, and metal finishing. The company offers prototyping and production solutions for surgical instrument manufacturers.

San Diego, CA

Based in San Diego, CA, Unified Orthopedics Inc. specializes in advancing innovation for total joint replacement. The company develops and manufactures clinically proven orthopedic products, including the EMPOWR Revision Knee, advanced revision knee cones, and dual mobility solutions for surgical use.

Monroe, WA

Based in Monroe, WA, Velocity MedTech specializes in the design and manufacturing of orthopaedic surgical instruments. The company offers integrated services, including product development, manufacturing, anodization, and supply chain simplification, partnering with clients from concept to delivery.

Medline specializes in manufacturing high-quality surgical instruments crafted from German stainless steel. Their production process adheres to a stringent 114-step protocol, which includes intricate machining and meticulous finishing. This detailed approach ensures precision and durability in all their surgical products.

Penn United Technologies Inc. is an ISO-certified organization specializing in precision manufacturing for high-quality medical device components. The company provides progressive stamping dies and injection molding services to meet modern industry demands.

Austin, TX

Based in Austin, TX, Texas Contract Manufacturing Group (TCMG) specializes in turnkey manufacturing, fabrication, and assembly. They offer high-precision machining for complex, high-value metal components, notably serving the medical device sector. TCMG emphasizes quality, reliable delivery, and expert production for intricate manufacturing needs.

Vantedge Medical is a precision metals manufacturing partner for medical OEMs, specializing in minimally invasive surgical instruments, drills, and power systems. They offer end-to-end metals expertise from prototyping to production, including precision machining, stamping, and electromechanical assembly for various medical devices.

Viant is a medical device design and manufacturing partner, collaborating with OEMs to accelerate speed to market and enhance product quality. The company offers comprehensive manufacturing capabilities, specializing in areas like interventional and inhalation devices for the MedTech industry.

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How to Choose a Company

  • Verify their ISO 13485 certification is current and specifically covers the scope of medical device manufacturing you require, not just general machining. Ask to see their most recent audit report and corrective actions, paying attention to non-conformances related to design controls or process validation.
  • Confirm their expertise in post-processing critical for surgical instruments, such as nitric acid or citric acid passivation to enhance corrosion resistance, and electropolishing for improved surface finish and cleanability. Understand their validation protocols for these processes, especially if your instrument will be reused and sterilized repeatedly.
  • For instruments with intricate internal geometries or fluid pathways, such as cannulated devices or endoscopes, confirm their capabilities in deep-hole drilling, deburring, and internal surface finishing. A common gotcha is inadequate internal cleaning and passivation, which can lead to contamination or device failure in the field.
  • Demand a clear roadmap for Unique Device Identification (UDI) marking and integration into their production workflow if your device requires it. A red flag is a manufacturer who dismisses UDI as 'just laser marking' without understanding its full regulatory implications for labeling, database submission, and supply chain management.

Supplier Types at a Glance

TypeBest ForTypical MOQ
Precision Micro-Machining SpecialistsCustom, intricate, or novel instruments; prototypes; R&D batches; delicate endoscopic components.1-50 units
General Surgical Instrument ManufacturersStandard reusable instruments; general surgery sets; mid-volume production; existing product lines.50-500 units
Orthopedic/Large Tool FabricatorsImplants; bone fixation devices; large orthopedic tools; high-volume components; trauma instruments.100-5000+ units
Turnkey Medical Device OEMsFull product development to finished goods; complex assemblies; regulatory support; ongoing supply chain management.500+ units (negotiable for complex, high-value devices)

Frequently Asked Questions

What specific biocompatibility standards must a surgical instrument manufacturer adhere to?

For surgical instruments, manufacturers must primarily adhere to ISO 10993 series for biological evaluation of medical devices. This includes parts covering cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, and for long-term contact devices, systemic toxicity or genotoxicity. The specific tests required depend on the instrument's intended use, body contact duration, and material composition. Always request proof of material biocompatibility and an understanding of the necessary tests for your device's risk classification.

How do traceability requirements differ for reusable vs. single-use surgical instruments?

While both reusable and single-use instruments require robust traceability, the emphasis shifts. For single-use devices, traceability primarily focuses on tracking raw material lots, manufacturing process parameters, sterilization records (if applicable), and final packaging to lot numbers, enabling efficient recalls. For reusable instruments, in addition to initial manufacturing traceability, there's a greater emphasis on material integrity over time, specific passivation and surface finish records, and often provisions for repair, refurbishment, and re-passivation, which adds layers to the ongoing traceability chain for each unique instrument.

Is it common for surgical instrument manufacturers to handle sterilization and sterile barrier system (SBS) packaging in-house?

While some larger, integrated manufacturers do offer in-house sterilization (e.g., EtO, gamma, e-beam) and sterile barrier system (SBS) packaging, it's more common for surgical instrument manufacturers to partner with specialized, validated contract sterilization and packaging facilities. Manufacturers typically produce and clean the instruments, then ship them to a sterilization partner. Buyers should clarify if the manufacturer manages this partnership as part of a turnkey solution or if they expect the buyer to coordinate the post-manufacturing sterile processing. Crucially, the manufacturer must understand the impact of sterilization on the instrument's materials and design.

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