Sterilization Equipment
229 vendors serving US medical buyers
Browse vendors of sterilization equipment (Sterilization & Infection Control) serving hospitals, clinics, laboratories, and other medical buyers across the United States. MedIndexer connects procurement and clinical-engineering teams with verified vendors supplying sterilization equipment. Browse detailed profiles, compare service areas, and contact vendors directly — free for buyers.
Featured sterilization equipment
Kentron Health Care, Inc.
Kentron Health Care, Inc. is a medical products distributor and supplier based in Springfield, Tennessee, offering a comprehensive portfolio of medical consumables, disposables, and equipment. The company's product range includes syringes, needles, IV sets, wound care supplies (dressings, gauze, bandages), gloves, personal protective equipment (PPE), surgical instruments, diagnostic equipment, respiratory care products, sterilization products, germicidal products, and specialized kits for EMS, OB/GYN, and medical applications. Kentron supplies burn care products, cold/hot therapy packs, diabetic care supplies, infusion products (including the Kenaflexx line), immobilization devices, laryngeal products, nursing supplies, and urology consumables. The company also distributes hospital plastics, textiles, sharps containers, surgical tapes, tools, and miscellaneous medical supplies. Kentron serves emergency medical services, hospitals, clinics, and healthcare facilities across the United States. The company maintains MSDS (Material Safety Data Sheet) documentation for chemical products and operates as a B2B supplier with a full-service catalog spanning multiple therapeutic areas and clinical departments. Their product distribution model emphasizes accessibility to healthcare providers through direct sales and a comprehensive ordering system.
ION BEAM APPLICATIONS S.A.
ION BEAM APPLICATIONS (IBA) is a global leader in particle accelerator technology, designing, producing, and marketing innovative solutions for cancer diagnosis and treatment, as well as industrial applications including medical device sterilization. The company operates across four primary business segments: Proton Therapy, providing advanced radiation therapy systems for oncology; Dosimetry & Quality Assurance, delivering measurement and verification tools for radiotherapy and radiation protection; RadioPharma Solutions, offering radiopharmaceutical production and diagnostic imaging solutions; and Industrial Solutions, serving sterilization, materials testing, and other industrial sectors. IBA's proton therapy systems represent cutting-edge particle beam technology for precision cancer treatment, while its dosimetry portfolio addresses quality control and safety verification in medical and industrial radiation environments. The RadioPharma segment encompasses cyclotrons, radiochemistry automation, and molecular imaging solutions for PET/SPECT diagnostics. Industrial applications include electron beam and ion beam technology for sterilization of medical devices and pharmaceutical products. The company serves hospitals, cancer centers, diagnostic imaging facilities, and industrial manufacturers globally, with a demonstrated track record of regulatory approvals and international certifications supporting clinical and industrial deployment.
ResearchDx, Inc.
ResearchDx is a comprehensive diagnostic development and contract research organization (CRO) specializing in in vitro diagnostic (IVD) test development, validation, and commercialization. The company operates three integrated divisions: Contract Services (biomarker discovery, assay development, regulatory filings); Diagnostic Laboratory (CLIA/CAP/ISO 15189 accredited clinical testing under the PacificDx brand); and Diagnostic Manufacturing (ISO 13485:2016 and GMP-compliant kit manufacturing under the CustomDx brand). Core capabilities include custom molecular assay development (PCR, qPCR, ddPCR, NGS, microRNA, protein, flow cytometry, ELISA), analytical and clinical validation, companion diagnostic development, and complete laboratory accreditation consulting. The company is ISO 13485:2016 certified, CLIA approved, CAP accredited, and FDA registered. Recent achievements include FDA 510(k) clearances for GlutenID celiac genetic health risk test and regulatory approvals for companion diagnostics (ProMarkerD for diabetic kidney disease, FibroSIGHT for MASH liver fibrosis detection). ResearchDx serves pharmaceutical companies, diagnostic startups, and established laboratories requiring integrated IVD development from concept through commercialization and contract manufacturing.
Millstone Medical Outsourcing LLC
Millstone Medical Outsourcing LLC is a contract manufacturing and post-manufacturing services provider headquartered in Mississippi serving medical device manufacturers globally. Founded in 2000, the company specializes in packaging, testing, logistics, and quality assurance for completed medical devices. Core capabilities include: packaging and assembly with ISO Class 7 cleanroom operations; quality-critical inspection and validation engineering; finished goods distribution and reverse logistics management including bone and tissue storage with cold-chain capability; set building and loaner management for surgical instruments; and comprehensive in-house testing services. Testing portfolio encompasses bioburden, sterility, bacterial endotoxin, microbial identification, particulate analysis, cytotoxicity, sterilization validation (gamma and ethylene oxide), EO residual testing, preservative efficacy, peel strength, dye penetration, bubble emission, accelerated aging, and environmental monitoring. The company operates 276,000 square feet of facility space with a 25,000-square-foot ISO 17025-certified laboratory featuring a world-class BI sterility suite for EO sterilization validation. FDA-registered and ISO 13485:2016 certified. Serves 50+ customers worldwide, including top-10 orthopedic device manufacturers. Offerings include pre-validated packaging solutions, system integration services, pharma-device distribution, and ImplantBase platform. Primary markets: orthopedics, surgical devices, and robotic-assisted surgery equipment.
TPR Medical Distributors, LLC
TPR Medical Distributors, LLC is a B2B medical supplies distributor based in Passaic, New Jersey, with operations in the Philippines. The company specializes in medical consumables and disposables, including examination gloves (vinyl and nitrile), sharps containers, medical tapes, sterile dressings, safety syringes, and wound care products. TPR functions as an exclusive distributor for established manufacturers including Dynarex, Dukal, Emerald, Nipro, DuoProSS, Crystal Quest, Molded Products, and Rockwell Medical. The company serves a broad market across multiple care settings: hospitals, nursing homes, clinics, emergency departments, dental practices, dialysis centers, dermatology/cosmetic surgery facilities, DME providers, and retail channels. Product categories span gloves and PPE, injectable safety devices, medical tapes, sterile dressings, sharps management, and customizable medical kits. TPR operates dual headquarters in the United States (New Jersey) and the Philippines, reflecting its role as a global supplier and distributor. The company maintains direct customer service and sales support in both regions.
PARTER STERILIZATION SERVICES / PARTER MEDICAL PRODUCTS
Parter Sterilization Services (PSS) is a contract sterilization service provider based in Southern California, specializing in Ethylene Oxide (EtO) and Electron Beam (E-beam) sterilization for medical device manufacturers. The company operates two facilities: an EtO sterilization facility in Carson, CA, and an Electron Beam facility in Ontario, CA. PSS offers vacuum-based EtO sterilization suitable for a wide range of medical device materials and gentle penetration sterilization, as well as high-energy electron beam irradiation for single-use medical devices, contamination control, and material modification applications including heat shrink tubing, cables, and molded parts. The company maintains 24/7 continuous operations to ensure rapid turnaround times and is fully registered with the State of California and the Federal Food and Drug Administration (FDA). PSS is ISO certified for quality systems and sterilization operations, meeting industry standards for precision and reliability. The company serves medical device manufacturers navigating regulatory requirements and seeking customized sterilization solutions with dedicated on-the-ground support.
Surgical Solutions, Inc.
Surgical Solutions is a procedural support and sterile processing services provider serving U.S. hospitals and surgical facilities. The company operates as a deeply embedded partner delivering comprehensive on-site support across operating rooms, endoscopy departments, and sterile processing departments (SPD). Service offerings include pre-operative instrument preparation, intraoperative surgical assistance, post-operative care, scope reprocessing, instrument repair, sterile processing leadership and consulting, vendor relationship management, capital equipment planning, and 24/7/365 on-site technician support. The company emphasizes process optimization, compliance adherence to industry standards (including Joint Commission), staff training and development, and efficiency improvements documented by case studies showing $1M in direct endoscopy savings, 70% increases in minimally invasive procedure volumes, and 95% reduction in unused surgical tray rates. Surgical Solutions employs a customized, collaborative approach to each facility's procedural and sterilization workflow challenges, with dedicated focus on patient safety, surgical team support, and operational reliability.
Steri-Tech, Inc.
Steri-Tech, Inc. is a contract sterilization service provider and distributor of disposable apparel and cleanroom products based in Salinas, Puerto Rico. The company operates as both a sterilization service bureau and a product distributor. Their primary service offering is contract sterilization—customers can track product sterilization status by phone. The company also distributes safety and disposable apparel products, including cleanroom-grade supplies. Their quality service objective emphasizes consistent value, compliance with specified requirements, and continuous improvement through controlled processes and appropriate facility management. The company maintains partnerships with manufacturers and serves healthcare and industrial clients requiring sterilization services and cleanroom-compatible consumables. As a Puerto Rico-based operation, Steri-Tech is positioned to serve US and Caribbean markets. The organization emphasizes customer satisfaction through responsible handling of products and process control, indicating compliance-oriented operations typical of sterilization service providers. Specific regulatory certifications are not explicitly detailed on the fetched content, though contract sterilization operations typically require FDA oversight and adherence to ISO 11135 or equivalent standards.
Asept Pak, Inc.
Asept Pak, Inc. is a sterile contract manufacturer and packager specializing in aseptic processing and packaging for medical devices and pharmaceutical products. The company employs Blow-Fill-Seal (BFS) technology to provide sterile manufacturing solutions with minimal contamination risk. The BFS platform offers flexibility in product compounding, packaging design, and formulation customization at competitive costs. Product portfolio includes sterile water for injection (WFI) USP, sterile saline solutions, ophthalmic drops, inhalation solutions, wound care products, purified water USP, sucrose formulations for neonatal use, laboratory test reagents, and eyewash solutions. The company serves healthcare facilities, pharmaceutical manufacturers, and medical device producers requiring aseptic processing capabilities. Asept Pak operates as a contract manufacturer, offering flexible manufacturing volumes and custom formulation support. The BFS technology platform enables simultaneous filling and sealing in sterile environments, reducing post-fill contamination risk compared to traditional aseptic filling methods. The company emphasizes cost-effectiveness and manufacturing flexibility for clients seeking alternative packaging and compounding solutions.
Klann Plastics
Klann Plastics is an ISO 9001:2015 certified precision custom injection molder and mold maker founded in 1910. The company is a UL-recognized molder and FDA-listed contract manufacturer of medical devices. They serve the medical device industry through custom plastic injection molding in cleanroom environments, mold design and building, insert molding and overmolding, metal-to-plastic conversions, and short-run production. Medical device manufacturing represents a significant portion of their business alongside industrial, HVAC, energy, consumer, telecom, electronic, and government/education sectors. Klann provides comprehensive quality control systems, inventory management, and mold maintenance services. Their cleanroom molding capabilities support stringent medical device production requirements. The company maintains strong relationships with Fortune 50 and regional manufacturers, emphasizing on-time delivery, product quality, and customer service.
MedSource Imaging
MedSource Imaging is the leading independent third-party provider of refurbished Hologic mammography equipment and parts, serving US and international facilities. The company specializes in high-quality refurbished Hologic mammography systems including Selenia Dimensions, Selenia 2D, Genius 3D, Affirm, SecurView, and Horizon DXA systems, priced at approximately 50% below new equipment costs. MedSource maintains the largest independent inventory of Hologic mammography parts and systems, including detectors, X-ray tubes, CPUs, monitors, paddles, workstation components, and biopsy devices. The company's comprehensive refurbishment process includes full restoration, calibration, component replacement, and testing to ensure systems meet MSI standards and deliver optimal performance. Service capabilities include rapid repairs, preventative maintenance, on-site and remote diagnostics, installation, transport, relocation, and removal. MedSource offers same-day parts shipping, nationwide service with 24-hour repair response, remote detector mapping assistance, and expert engineering consultation for parts matching. The company also purchases used Hologic mammography, DXA, and C-arm systems for resale. All equipment includes warranty support and 100% customer satisfaction guarantees. Experienced technical team handles turn-key imaging solutions and provides expert Hologic equipment expertise. The company has installed systems across multiple facilities and maintains an extensive parts inventory ready for immediate shipment.
PRACTICON, INC.
Practicon, Inc. is an established dental supplier founded in 1982, specializing in practical innovations and comprehensive dental products and supplies for dental practices. The company curates over 3,000 dental products spanning sterilization and infection prevention, personal protection equipment, examination and hygiene supplies, treatment supplies, restorative materials, patient education tools, and home care preventive products. Practicon partners with leading dental manufacturers including Hu-Friedy, Dentsply Sirona, GC America, Kerr, Premier Dental Products, Woodpecker, Garrison, Pentron, and others to deliver a broad portfolio supporting clinical operations, office management, and patient care. Operating as a family-oriented distributor, Practicon serves dental practices with bulk ordering capabilities and membership programs.
LEGEND MEDICAL DEVICES
Legend Medical Devices, Inc. is a manufacturer and distributor of FDA-approved and ISO-certified respiratory care, CPAP, anesthesia, and infection control disposables. A subsidiary of Asia Healthcare Holdings, the company designs, manufactures, imports, and distributes medical products for airway management and respiratory support through partnerships with manufacturing companies in China, Korea, and other Asian markets. The company supplies healthcare facilities and professionals with a comprehensive product portfolio spanning CPAP systems (masks and tubing), anesthesia disposables (laryngeal mask airways, endotracheal tubes, breathing circuits), respiratory care products (nasal cannulas, oxygen masks, suction catheters, tracheostomy care items, nebulizers), and sterilization wraps and pouches. Products are marketed for hospital, clinical, and homecare settings. Legend emphasizes cost-effective, quality products with customer service and R&D as core differentiators. The company operates as a B2B supplier to hospitals, healthcare systems, distributors, and authorized dealers and sales representatives.
SCANLAN INTERNATIONAL, INC.
Scanlan International, Inc. is a family-owned manufacturer of precision handcrafted surgical instruments established in 1921 and based in Saint Paul, Minnesota. Operating in their fourth generation, the company specializes in cardiovascular, microsurgical, minimally invasive, and temporary occlusion surgical instruments. Scanlan manufactures reusable and single-use surgical instruments including forceps, needle holders, scissors, clamps, retractors, suction instruments, and specialized tools for VATS/MIS procedures. The company is renowned for its proprietary products such as VASCU-STATT® bulldog clamps, Reliance Bulldog clamps, and the SCANTURIAN® minimally invasive surgical instrument line. All instruments are handcrafted using premium medical-grade stainless steel and titanium with advanced coatings for enhanced durability and performance. Scanlan offers comprehensive support services including instrument restoration, modification, cleaning and sterilization guidance, warranty coverage, and custom modifications. The company collaborates closely with surgeons across specialties to design and refine instruments for evolving procedural needs, serving hospital operating rooms and surgical teams globally.
Tapecon Inc.
Tapecon, Inc. is a fifth-generation family-owned contract manufacturer headquartered in Buffalo, New York, founded in 1919. The company specializes in custom converting, printing, and advanced manufacturing services for original equipment manufacturers (OEMs) in healthcare, life sciences, electronics, and industrial sectors. Tapecon offers end-to-end manufacturing solutions including medical device labels, cohesive tapes, membrane switches, and flexible hybrid electronics. The company provides specialized capabilities in screen printing, flexographic printing, digital printing, and cleanroom converting for sterile medical applications. With over 100 employees, Tapecon focuses on helping product managers and engineers reduce time-to-market while optimizing costs. The company has pioneered on-body monitoring devices and wearable biosensors, and continues to expand into flexible electronics and digitization of diagnostic components. Tapecon combines design consultation, prototyping, and full-scale production services tailored to medical device OEM requirements.
LYNX Medical
LYNX Medical is an ISO 13485-certified, FDA-registered contract manufacturer and sterilization service provider serving the medical device industry. The company operates facilities in Pennsylvania and New Jersey, offering three primary service lines: contract assembly and cleanroom packaging for early-stage and full-scale medical device production; ethylene oxide (ETO) sterilization processing compliant with ISO 11135; and sterilization validation support. LYNX Medical guarantees 24-hour ETO processing turnaround for devices packaged in-house and commits future sterilization capacity throughout a product's lifecycle. The company positions itself as a supply chain optimization partner, reducing lead times and eliminating logistics costs through integrated packaging and sterilization services. All operations meet regulatory requirements and industry standards for medical device manufacturing and processing.
AVANTTI MEDI CLEAR MBP, S.A.P.I. DE C.V.
Avantti Medi Clear is a medical device sterilization services provider specializing in electron beam (E-Beam) technology. The company operates a facility in Tijuana, Mexico, serving clients across Mexico and the southwestern United States. They offer comprehensive sterilization services for a wide range of medical consumables and devices, including syringes, catheters, IV sets, blood bags, blood transfusion bags, endotracheal tubes, gloves, pipettes, and sample bottles. The company provides sterilization processing, dose mapping, validation studies, and product testing to ensure compliance with international regulatory standards. Avantti Medi Clear holds FDA approval, COFEPRIS (Mexican regulatory) certification, and C-TPAT (Customs-Trade Partnership Against Terrorism) compliance, ensuring regulatory adherence for cross-border shipments. Their E-Beam technology uses electrical energy rather than chemicals or radioactive materials, positioning their process as both a safety-compliant and environmentally sustainable sterilization solution. The facility is designed to maintain product integrity while providing rapid turnaround times for manufacturers seeking contract sterilization services.
National Hospital Packaging / NHP Surgi-Pak, Inc.
National Hospital Packaging (now operating as NHP Surgi-Pak) is a pioneer in pre-packaged and custom-packaged sterile surgical supplies with over 40 years of industry experience. The company specializes in FDA Class I medical device packaging and sterilization, serving operating rooms, emergency departments, and other healthcare settings requiring sterile single-use products. All products are individually sealed in aseptic-opening poly pouches and sterilized using gamma irradiation, ensuring product integrity and sterility compliance with ANSI/AMMI/ISO standards. Product lines include surgical sutures (Atlas Trauma stainless steel 316L monofilament), sterile cast padding, sterile cotton-tipped applicators, and sterile vaginal packing, among other customizable offerings. The company operates as a FDA-regulated Class I medical device provider (FDA registration #2028046) and offers same-day shipment from stock for orders placed by 1:00 PM Pacific Time. Manufacturing and sterilization capabilities include gamma irradiation processing and custom packaging per customer specifications. The company maintains direct customer service with live support staff available during business hours (7:30 AM–4:00 PM Pacific, Monday–Friday) and emphasizes product safety, labor savings, and adherence to regulatory standards.
RADIATION PRODUCTS DESIGN, INC.
Radiation Products Design, Inc. (RPD) is a specialized manufacturer and supplier of radiation therapy, diagnostic imaging, and nuclear medicine accessories and equipment. Based in Albertville, Minnesota, RPD serves medical physics, radiation oncology, and nuclear medicine departments across the United States. The company's product portfolio spans multiple therapeutic and diagnostic domains: radiation therapy positioning and immobilization systems (thermoplastic masks, vacuum cushions, head supports, breast positioning devices); brachytherapy applicators and accessories for both low-dose rate (LDR) and high-dose rate (HDR) gynecological applications; dosimetry and quality assurance equipment including build-up caps for ion chambers (Farmer, Exradin, PTW, Scanditronix/Wellhofer models), MOSFET and diode systems, electrometers, and radiation area monitors; CT simulator and imaging accessories such as CT chambers, phantoms, marking systems, and alignment lasers; shielding products including lead blocks, eye shields, tungsten shields, and mobile radiation barriers; calibration phantoms and water phantom systems; PET/nuclear medicine workstations, storage containers, and shipping systems; and sterilization/disinfection equipment and trays. RPD manufactures custom block room products (alloy dispensers, styrofoam blocks, cooling plates), bolus materials (Aquaplast, SuperFlab, moldable options), and precision beam modification tools. The company also supplies marking and positioning consumables, measuring instruments, lead-lined containers, and quality control devices (ISIS QA phantoms, beam analyzers). Products are compatible with major linear accelerator and imaging equipment manufacturers including Varian, Siemens, and Elekta. The company maintains a comprehensive PDF catalog and offers custom manufacturing for specialized applications. RPD serves hospital radiation oncology departments, medical physics groups, nuclear medicine facilities, and diagnostic imaging centers, providing both stock products and made-to-order solutions for radiation protection, dose verification, and treatment planning.
Medline ReNewal
Medline Industries, LP is the largest provider of medical-surgical products and supply chain solutions in North America, headquartered in Northfield, Illinois. With nearly 60 years of experience and over 45,000 employees globally, Medline operates 29 million+ sq ft of warehousing across 45+ U.S. distribution centers, delivering next-day service to 95% of customers. The company manufactures and distributes a comprehensive portfolio of approximately 335,000 medical-surgical products spanning all points of care—from acute care facilities to home settings. Core offerings include surgical solutions, front-line care products, laboratory and diagnostic supplies, durable medical equipment (DME), mobility aids, sterile processing and perioperative supplies, and laboratory consumables. Medline combines world-class product innovation with supply chain resilience and clinical solutions, enabling healthcare providers to improve clinical outcomes, reduce costs, and optimize operations. The company serves as a trusted manufacturing and distribution partner across hospitals, ambulatory surgery centers, long-term care facilities, and home healthcare providers.
Micropulse, Inc.
Micropulse, Inc. is an orthopedic manufacturing and supply company founded in 1988 and headquartered in Columbia City, Indiana. Since 2003, the company has focused exclusively on the orthopedic market, serving major, mid-tier, small, and start-up orthopedic device and implant companies. Micropulse manufactures precision orthopedic instruments, orthopedic implants, custom surgical cases and trays, and provides sterile packaging services. The company operates under a Quality Management System compliant with ISO 13485:2016 and 21 CFR Part 820, positioning it as a regulated medical device manufacturer. Core capabilities include CNC machining, assembly, sterilization, and custom packaging for complete product solutions delivered under single purchase orders. Micropulse differentiates through vertical integration—machining, assembly, sterilization, and packaging under one roof—enabling customers to source implants and instruments from a single supplier with streamlined supply chain management. The company emphasizes quality, regulatory compliance, continuous improvement, integrity, and responsive customer service. Micropulse serves as a contract manufacturer and supplier for orthopedic OEMs and device companies navigating evolving regulatory requirements, price compression, and market consolidation. The company is led by CEO and Founder Brian Emerick.
SteriCUBE Surgical Systems, LLC
SteriCUBE Surgical Systems manufactures the SteriCUBE® Multiple Tray Sterilization System, a patented rigid sterilization container technology that eliminates traditional blue wrap and streamlines surgical instrument sterilization and OR workflows. The system features a patented funnel floor design with cross-ventilation filters optimized for steam sterilization, validated for 0.7mm penetration and smaller than competing technologies. SteriCUBE containers enable rapid autoclave processing with 5-minute dry times, direct placement in operating rooms without additional unwrapping steps, and integration into sterile processing departments (SPD) to reduce labor, materials costs, and processing time by approximately 27 minutes per surgery. The company operates a consignment-based business model, positioning SteriCUBE as a service rather than capital equipment purchase. The system addresses key operational pain points: elimination of blue wrap holes and compromised sterility, faster OR set-up and case start times, reduced SPD wrapping and prep labor, and improved inventory management by eliminating loaner tray wrapping. FDA cleared (510(k) K222328) and designed for healthcare facilities seeking workflow efficiency, cost reduction, and patient safety improvements in the OR and SPD environments. SteriCUBE is backed by peer-reviewed research and customer testimonials from major healthcare systems.
UNITED BIOTECH
United Biotech is a global provider of enzymatic and non-enzymatic cleaning and disinfecting solutions for hospital and healthcare facilities. Established in 2003, the company specializes in medical device decontamination, including endoscope reprocessing, instrument passivation, and multi-step cleaning chemistries. United Biotech formulates FDA-registered Class I medical devices designed to prevent hospital-acquired infections while protecting instrument integrity. Their portfolio includes enzymatic detergents, high-level disinfectants, sterilants, and specialist solutions for diverse decontamination challenges. Products are competitively priced, environmentally safe (meeting Greenworks standards), and supported by quality assurance protocols and independent clinical studies. The company collaborates with global decontamination experts to optimize cleaning efficacy and regulatory compliance across hospital infection control operations.
DWK LIFE SCIENCES, LLC.
DWK Life Sciences is a global manufacturer and supplier of premium laboratory glassware, primary packaging solutions, and related consumables for the life sciences industry. Formed in June 2017 from the merger of DURAN Group, Wheaton Industries, and Kimble Chase, the company operates 11–12 manufacturing sites across Europe, North America, and Asia with approximately 1,700 employees. The company maintains a portfolio of over 25,000–30,000 products under the trusted brands DURAN®, WHEATON®, and KIMBLE®. Core offerings include borosilicate laboratory glassware (bottles, vials, flasks, beakers, tubes, volumetric ware), diagnostic test packaging components, cryogenic storage vials, caps and closures, pipettes, laboratory equipment, and customized solutions. DWK provides specialized services including particulate cleaning (Ready-to-Sterilize), sterilization (Ready-to-Use), barcoding, labeling, marking, and custom secondary packaging—all designed to meet USP and European Pharmacopoeia standards. Primary markets served include drug discovery, life science research, diagnostic testing, specialty pharmaceuticals, and in vitro diagnostic manufacturing.
True Indicating LLC
True Indicating LLC is a sterilization and disinfection technology innovator established in 2017, specializing in customized biological and chemical indicators for healthcare, dental, pharmaceutical, industrial, and life science applications. Based in Toledo, Ohio, the company combines over 35 years of combined expertise in microbiology and healthcare technology to develop indicators for traditional sterilization modalities (steam, ethylene oxide, hydrogen peroxide, dry heat, irradiation, formaldehyde, chlorine dioxide) and emerging technologies. True Indicating manufactures biological indicators (BIs), self-contained BIs (SCBIs), inoculated carriers, chemical indicator inks, tapes, integrators, and emulators. The company offers on-site inoculation, propagation of custom organisms, resistance verification testing, sterilization process validation, and consulting services. FDA-registered and ISO 13485:2016 certified, True Indicating provides scaled production with in-house manufacturing infrastructure and serves thousands of healthcare customers requiring quality sterilization assurance and compliance solutions.
MASTEL SURGICAL INC.
Since 1981, Mastel Surgical has been a leading manufacturer of precision microsurgical instrumentation, particularly renowned for diamond scalpels that have set standards in ophthalmic surgery. The company specializes in ultrathin, minimally invasive instruments designed to enhance surgical precision for ophthalmologists. Building on decades of surgical expertise, Mastel Surgical has expanded into sterile processing solutions, offering a comprehensive product range including instrument cleaning systems, identification and organization tools, care and protection products, and pack-and-prep solutions. These sterile processing offerings enable healthcare facilities to maintain the highest safety and cleanliness standards. ISO 13485:2016 (MDSAP) certified, FDA-registered, and Health Canada approved, Mastel Surgical serves surgical centers, hospitals, and eye care facilities with both innovative surgical instruments and critical sterilization infrastructure support.
Voltas Medical LLC
Voltas Medical LLC is a vertically integrated medical device development and manufacturing partner headquartered in Cottage Grove, Minnesota. The company provides accelerated, end-to-end services for medical device commercialization under a single project manager, budget, and timeline. Core capabilities span R&D and rapid weekly prototyping (using Arduino, Raspberry Pi, sensors, LCD screens), regulatory services (510k submissions, PreSub/513g work), contract manufacturing (plastic injection molding, micro-molding, die-mold tooling), specialized processes (balloon development, hydrophilic/hydrophobic coatings, UV laser etching, RF and ultrasonic welding), in-house ETO sterilization with validation, packaging and blister tray development, and post-launch support including distribution, warehousing, medical sales, and marketing. The company targets Class I and Class II medical devices and claims capability to bring products to market in under 2 years for under $1 million. Device specialties include ablation catheters, stent delivery systems, diagnostic imaging, laparoscopic instruments, bone plates, endovascular grafts, neurostimulation devices, and vascular catheters.
De Soutter Medical USA, Inc
De Soutter Medical Limited is a leading British manufacturer of powered surgical instruments and medical devices based in Aylesbury, England. Founded in 1990, the company specializes in high-performance, cost-effective surgical power tools for orthopedic, trauma, cardiothoracic, neuro-ENT, and plastic surgery applications. The product portfolio includes over 800 items spanning modular and dedicated instruments powered by battery, electric, or pneumatic options. Key product lines include ORTHODRIVE® systems for large bone surgery, OSTEODRIVE® II for extremity procedures, TRAUMADRIVE™ for trauma applications, hekaDrill™ for neuro-ENT work, arthrodrive® shaver systems for arthroscopy, sternudrive™ sternum saws for cardiothoracic procedures, and dermadrive™ for plastic surgery. The company also manufactures cast removal systems (CleanCast™ and QuietCast™), autopsy saws, and the Stericut® brand of sterile-packed consumables including burs, blades, drills, and K-wires. Additionally, De Soutter offers pulse lavage systems (EcoPulse™) and comprehensive accessories including batteries, chargers, and sterilization containers. ISO 13485 certified, the firm maintains global distribution with offices across Europe, North America, and Australia, serving hospitals, surgical centers, and orthopedic practices.
EAGLE MEDICAL, INC.
Eagle Medical, Inc. is a medical device packaging and sterilization service provider specializing in blister tray and pouch packaging. The company operates a 20,000 square-foot ISO 13485:2016-certified facility in Paso Robles, California, featuring over 2,500 square feet of ISO 14644-1 Class 7 cleanrooms. Services include contract sterilization (hydrogen peroxide gas plasma, E-beam, ethylene oxide, and gamma beam irradiation), contract assembly and packaging, package design, tooling design and fabrication, and comprehensive validation support (sterilization, packaging, cleaning, and process validation). The company also provides regulatory consulting for 510(k) and PMA submissions, incoming inspection, device master records, batch records, and protocol development. Eagle Medical serves OEM medical device manufacturers with expertise in GMP compliance, vendor audits, and inventory control systems.
Boulder iQ
Boulder iQ is a specialized life sciences consulting and contract services firm headquartered in Boulder, Colorado, providing comprehensive support to medical device, diagnostic, and combination product companies. The firm operates as a family of integrated companies: Boulder iQ (engineering, design, development, and manufacturing); Boulder Sterilization (contract sterilization services); Boulder Regulatory Affairs and Quality Assurance (regulatory and QA support); and Boulder BioLabs (contract testing and validation). With over 40 years of collective expertise and ISO 13485:2016 certification, Boulder iQ serves clients across 33 U.S. states and 6 countries. The company specializes in concept-to-commercialization support, including product design, prototyping, manufacturing, quality systems, regulatory pathway navigation, and sterilization validation. Boulder Sterilization is recognized as the sole U.S. contractor offering both ethylene oxide and chlorine dioxide sterilization, and the world's largest contract chlorine dioxide sterilizer.
Mount Mfg
Mount Mfg is a contract manufacturer of medical devices founded in 2015, specializing in orthopedic implants and instruments. Operating from a state-of-the-art 10,000 sq ft facility in Marquette, Michigan, the company serves the Spine, Extremity, Orthopedic, Trauma, and Dental industries. Core competencies include CNC Swiss turning and milling (up to Ø38mm with 5-axis capability), secondary finishing (bead blasting, tumbling, buffing, polishing), laser marking for UDI compliance, and cleaning & passivation services. Quality infrastructure incorporates Industry 4.0 principles with real-time production monitoring, rigorous GD&T standards training, advanced inspection technology, and full regulatory compliance support for global markets. The company is committed to precision manufacturing and maintaining effective quality systems to meet evolving regulatory requirements.
C2C Development, LLC
C2C Development, LLC is an FDA-registered, ISO 13485:2016-certified contract manufacturer and product development firm specializing in medical device design, prototyping, and low-volume manufacturing. The company operates a certified ISO 7 (Class 10,000) cleanroom environment and serves medical device innovators across laparoscopic, endoscopic, orthopedic, intravascular, neurological, stereotactic, and drug delivery applications. Services include comprehensive design control and prototyping using 3D modeling, 3D printing, conventional machining, and CNC machining; component sourcing and supplier qualification under ISO 13485 quality systems; assembly and packaging operations including kitting, cleaning, and inspection; verification and validation testing including packaging seal integrity, shelf-life, and mechanical/functional testing; sterilization management and laboratory testing coordination; and regulatory strategy consultation and submission support. The firm specializes in manual and semi-automated assembly for products that larger OEMs may not accommodate, enabling manufacturers to scale from pilot production to commercial release under either C2C's or the client's quality system. Clients include Medtronic, FHC, Monteris, and other established medical device manufacturers.
Medicar Health Inc.
Rexmed Health is a medical device original equipment manufacturer (OEM) and contract manufacturer based in El Paso, Texas, with a manufacturing plant in Ciudad Juarez, Mexico. The company specializes in designing, engineering, and manufacturing medical devices for parenteral delivery, infusion therapy, and specialty applications. With over 20 years of experience, Rexmed manufactures products serving ophthalmic surgery, urology, parenteral nutrition, IV therapy, cardiology, airway management, and pain management sectors. Core manufacturing capabilities include fluid delivery sets, infusion pump systems, parenteral bags and configurations, and surgical dispensing coils, produced in certified clean rooms (Class 8 environment). The company holds FDA approval, COFEPRIS (Mexican regulatory) certification, CT-PAT customs certification, and operates under cGMP compliance. Rexmed provides integrated services including process validation (IQ/OQ/PQ), sterilization management, logistics and warehousing, testing services, and master validation planning. The company works with major national and multinational pharmaceutical organizations and emphasizes customized solutions, hand assembly capabilities, special testing, and small-lot production flexibility. Rexmed maintains lean enterprise methodology with six sigma practices and is recognized as a socially responsible company (ESR) by the Mexican Center for Philanthropy. Distribution and logistics partnerships include Silan Medexo (import/export), Doniphan Logistics (distribution center), and PJ Technologies (infusion pump system distribution).
Diamond Diagnostics Inc.
Diamond Diagnostics Inc. is a specialized clinical laboratory instrumentation and consumables supplier based in Holliston, Massachusetts, founded in 1996. The company manufactures, remanufactures, and supplies new and refurbished chemistry analyzers, electrolyte analyzers, immunoassay systems, blood gas analyzers, coagulation analyzers, hematology analyzers, and molecular analyzers. With approximately 80 employees and ~$19M annual revenue, Diamond offers over 500 consumable products including reagents, quality controls, and electrodes. The company's proprietary Down-To-Frame® refurbishment process restores equipment to like-new condition. Most products hold FDA clearance and CE approval. Diamond provides comprehensive field service, depot service, preventive maintenance, remote support, control assay, and refurbishment services to clinical laboratories and hospitals globally. ISO 9001:2015 and ISO 13485:2016 certified, the company also offers OEM and contract manufacturing for third-party organizations.
Medivest Group
Block Imaging is a global leader in refurbished medical imaging equipment, parts, and multi-vendor service solutions. Founded in 1997 and headquartered in Holt, Michigan, the company employs over 300 team members across facilities in Michigan, California, France, and Japan. ISO-9001 certified and serving healthcare providers in over 100 countries, Block Imaging specializes in extending the operational life of diagnostic imaging systems across multiple modalities and vendors. The company offers a comprehensive ecosystem comprising 40,000+ validated imaging parts, flexible multi-vendor service with nationwide engineers, equipment sourcing and trading services, and rapid on-site support for U.S. customers. Block Imaging's Sourcing Window Pro platform enables centralized purchasing and inventory management. The company focuses on reducing equipment downtime, controlling costs, and maintaining performance consistency across aging and legacy imaging systems when original manufacturer support ends.
Custom Manufacturing, Inc.
Custom Manufacturing Incorporated is a non-automated contract manufacturer specializing in single-use and disposable medical devices, electrosurgical devices, and cardiac insulation pads classified as Class I medical devices. Founded in 1996, the company provides comprehensive manufacturing, assembly, packaging, and labeling services for medical device manufacturers and OEMs. Manufacturing capabilities encompass simple to complex assembly operations, including kit assembly, with flexibility to accommodate client specifications. Packaging services include pneumatic, heat, impulse, and other sealing methods ensuring packaging integrity and seal strength. The company offers detailed labeling capabilities from basic information labels to Microscan LVS barcode labels. The facility includes a state-of-the-art ISO Class 7 controlled clean-room environment certified per ISO Standard 14644-1:2015, enabling production of sterile and contamination-controlled medical devices. The company also manufactures non-medical devices. Operating from Elbert, Colorado, Custom Manufacturing serves medical device manufacturers requiring domestic contract manufacturing with quality assurance and regulatory compliance. The facility's large production area supports simultaneous manufacturing, cleaning, packaging, labeling, and assembly of multiple product lines.
Tegra Medical Costa Rica S.A.
Tegra Medical is a global contract manufacturer specializing in end-to-end production of medical devices. Headquartered in Franklin, Massachusetts, with manufacturing facilities across the United States, Costa Rica, Switzerland, and Asia, the company employs over 1,000 people. Tegra Medical delivers comprehensive manufacturing solutions including design, prototyping, precision production, assembly, packaging, and sterilization for complex metal and plastic components. The company serves multiple therapeutic areas including oncology, orthopedics, cardiology, minimally invasive surgery, ophthalmic, women's health, drug delivery, and robotic-assisted surgery applications. Advanced manufacturing capabilities include Swiss machining, multi-axis milling, injection molding, wire grinding, and precision finishing. Tegra Medical maintains ISO 13485 certification and FDA registration, supported by rigorous quality management systems. The company also operates Quick Wire & Tubing, an e-commerce platform offering in-stock and custom wire, tubing, and secondary processing services for medical device development and prototyping.
QMed Master Distribution LLC
QMed is a wholesale medical, surgical, dental, and laboratory product distributor serving health systems, ambulatory surgical centers, physicians' offices, urgent care facilities, emergency medical services, and post-acute care providers throughout the United States and internationally. Operating from an ISO-certified 180,000+ square foot distribution center, QMed maintains over 11,000 individual SKUs including advanced wound care, respiratory equipment, IV therapy supplies, diagnostic instruments, orthopedic products, sterilization equipment, and infection control supplies. Since 1990, the company has partnered with national distributors, regional independents, and retailers to optimize supply chain efficiency, reduce total cost of goods, and enhance product portfolios through world-class sourcing capabilities and deep healthcare industry expertise.
Pomee Corporation
3D Dental Designs & Development is a comprehensive dental supply distributor and manufacturer operating a global network of production facilities. The company supplies over 1,000 SKUs across endodontics, dental restoratives, impression materials, preventive and hygiene products, surgical instruments, X-ray equipment, and infection control products. Serving dental professionals and distributors, 3D Dental offers competitive pricing and private-label opportunities, enabling distributors to build brand recognition while accessing proven, clinically-trusted dental solutions. The company functions as a one-stop supplier for dental office needs, combining sourcing expertise with manufacturing partnerships to deliver high-quality, economically-priced products.
Jersey Dental Supplies
Jersey Dental Supplies is a B2B dental distributor based in Lakewood, New Jersey, specializing in comprehensive supplies for general and specialty dental practices. The company offers an extensive catalog of impression materials (vinyl polysiloxane, polyether, alginate), restorative materials (composites, glass ionomers, bonding agents, cements and liners), temporary and permanent crown and bridge materials, endodontic sealers, infection control products (sterilization pouches, ultrasonic solutions, disinfectants, PPE), finishing and polishing systems, diagnostic supplies including X-ray materials, surgical products, and accessories. Jersey Dental Supplies serves dentists and dental laboratories with quality products from established manufacturers, competitive pricing, personalized sales support, and fast shipping with easy returns.
Steritec Services LLC
Steritec Services LLC is a contract sterilization and biological testing provider specializing in medical device processing. The company operates a 54,000 square foot facility in Athens, Texas, equipped with ethylene oxide (EO) and steam sterilization chambers, along with comprehensive chemical and biological testing laboratories. Core services include 100% ethylene oxide sterilization, steam sterilization, sterility testing, LAL endotoxin analysis, EO residuals testing, and bioburden assessment. The company serves medical device manufacturers requiring validated sterilization processes and regulatory-compliant testing support, including ISO 11135 process validation, biological indicator testing, and process validation documentation. Steritec also provides professional consulting guidance for regulatory compliance and sterilization program development.
Novex Innovations
Novex Innovations is a contract development and manufacturing organization (CDMO) specializing in the design, development, and commercialization of biologics, pharmaceuticals, medical devices, and bioengineered tissue. Operating a 36,000 square-foot cGMP-compliant facility with Class 100 and Class 1,000 cleanroom spaces, the company provides comprehensive services spanning product and process development, clinical and commercial manufacturing, regulatory support, and distribution. Capabilities include biological formulations, clinical formulation, tissue processing, active pharmaceutical development, diagnostic materials manufacturing, and inventory management. ISO 13485 certified and FDA-registered, Novex supports clients from proof-of-concept through all phases of clinical trials to commercial scale-up and market distribution, serving both startups and multinational organizations across national and international markets.
KIRO GRIFOLS, S.L.
Grifols is a leading global biopharmaceutical and healthcare company founded in 1909, headquartered in Barcelona with significant US operations. The company operates across four primary business divisions: Biopharma (plasma-derived medicines and biopharmaceuticals for immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases), Diagnostic (blood screening and transfusion medicine diagnostics), Bio Supplies (plasma collection and processing supplies), and Healthcare Solutions for Hospitals (hospital equipment and consumables). Grifols manufactures and distributes innovative plasma-derived therapeutic products, clinical laboratory equipment and reagents, diagnostic assays, and healthcare infrastructure solutions for hospital and transfusion medicine settings. The company operates a global plasma donation center network and engages in research and development across multiple therapeutic areas, including immunological disorders, rare diseases, and infectious disease screening. Grifols maintains regulatory compliance with FDA approvals (evidenced by recent malaria blood screening assay approval), ISO standards, and international quality certifications. The company serves healthcare systems, blood banks, hospitals, clinical laboratories, and patients globally, with established operations and partnerships across the Americas, Europe, and Asia-Pacific regions.
EDM 3, LLC
EDM 3, LLC is a medical consumables and laboratory supplies distributor headquartered in Jacksonville, Florida. The company supplies over 300 stains and reagents for laboratory use, water collection and sample bottles (sterile, with or without sodium thiosulfate), sterilization monitoring products including biological indicators for autoclaves and sterilizers, and specialized dermatology instruments including biopsy punches and curettes for routine dermal procedures. The product portfolio also includes medical examination lamps engineered for enhanced brightness output (30% increase over conventional gas-filled models) with proven longer life, rechargeable 3.5V batteries for medical devices, and CitraStat®RX, a citrus-based deodorizer spray. The company markets ProSure® as a testing service with 24-hour results availability. EDM 3 serves laboratory, surgical, sterilization compliance, and dermatology/aesthetics markets. Products are positioned as quality replacements and hard-to-find specialty items for clinical practice settings, hospitals, and diagnostic laboratories.
BD Medical Development
Becton, Dickinson and Company (BD) is a global medical technology leader founded in 1897 with approximately $20.2 billion in FY2024 revenue. BD supplies a comprehensive portfolio spanning diagnostic and laboratory solutions, surgical products and instruments, medication management systems, and infection prevention technologies. The company pioneered disposable syringes (Plastipak™) and blood collection systems (BD Vacutainer®), and operates automated blood culture and diagnostic platforms. Through strategic acquisitions including CareFusion and C.R. Bard, BD expanded capabilities in medication management, surgical interventions, and hospital systems. Current offerings address ambulatory surgery centers, diagnostic accuracy and specimen collection workflows, patient safety and infection control, advanced clinical analytics through BD HealthSight Advisor, medication management optimization, and surgical efficiency. BD Incada™ Connected Care Platform represents the company's digital health integration strategy. With global operations across alternate sites, diagnostic labs, research areas, hospital units, pharmacy, and surgical suites, BD serves healthcare systems seeking integrated solutions to improve patient outcomes and operational efficiency.
SteriZign Precision Technologies, LLC
SteriZign Precision Technologies, LLC manufactures custom sterilization trays designed to store, protect, transport, and sterilize medical devices while meeting standards set by AMMI, AORN, OSHA, and FDA. Products have been pre-validated for steam sterilization and washing systems. The company offers three primary product lines: Kustomyz™ fully customizable trays allowing selection of dimensions, ventilation patterns, latches, handles, colors, and printing; Optimyz™ pre-engineered standard-sized trays with options for custom brackets, colors, logos, and printing; and Standardyz™ ready-to-order standard-sized trays with optional brackets and protective matting. Additional offerings include custom caddies for screws and implants, pouch sterilization racks, silicone finger mats, and mesh sterilization baskets. SteriZign provides design customization including laser etching, screen printing, and bright color options. The company utilizes 3D modeling, rapid prototyping, and level-based prototype development (with optional hard-coating or enhanced plating for decontamination compatibility). Services include device analysis, cycle compatibility evaluation, industry compliance cross-referencing, and transparent web-based project tracking. Development timelines range from 1–2 weeks for prototype drawings to 8–10 weeks for production orders.
CARNEGIE SURGICAL LLC.
Carnegie Surgical LLC manufactures and distributes specialty surgical instruments for general surgery, plastic surgery, ENT, anesthesia, and oral-maxillofacial applications. The company specializes in high-quality stainless steel instruments including laryngoscopes, retractors, haemostatic forceps, curettes, uterine dilators, catheter guides, and hand surgery sets. They also supply sterile processing equipment such as wire baskets and mesh trays for instrument sterilization. Carnegie Surgical serves hospitals, surgical centers, and dental practices with both standard catalog items and custom OEM solutions. Founded in 2005, the company emphasizes continuous improvement in product quality and competitive pricing, with a commitment to customer service and clinical standards.
Advance-Esthetic LLC
Advance-Esthetic is a B2B supplier of professional aesthetic and MedSpa equipment based in Fort Lauderdale, Florida. The company specializes in high-quality machines for facial, body, and skincare treatments tailored for estheticians, spas, and medical spas. Product portfolio includes facial aesthetics equipment such as microdermabrasion machines, LED light therapy devices, and multifunction facial systems; body aesthetics solutions including cellulite reduction, body contouring, and non-surgical skin tightening machines; aesthetic laser systems for cosmetic applications; and oxygen facial machines. Additionally, Advance-Esthetic supplies essential spa equipment including sterilization tools, wax warmers, and massage tables. The company features products from reputable brands, particularly Zemits. Beyond equipment supply, Advance-Esthetic offers comprehensive training through their online academy, personalized Q&A sessions with qualifying purchases, marketing support, financing programs, and lifetime customer support. The company operates showrooms in Fort Lauderdale, Manhattan, San Diego, and Dallas, and maintains global distribution with worldwide shipping capabilities.
MediDent Solution LLC
MediDent Solution LLC is a premier B2B distributor of high-quality dental and medical equipment, supplies, and consumables headquartered in Santa Ana, California. The company supplies dental professionals and practices with cutting-edge technology and essential supplies including carbide and diamond burs, sterilization pouches, ultrasonic cleaning solutions, infection control products, disposables, lubricants, and preventative care items. With a focus on customer satisfaction, fast shipping, 24/7 customer support, and strategic partnerships with leading manufacturers, MediDent Solution leverages efficient distribution networks to deliver comprehensive product selection and value. The company maintains a broad catalog of dental instruments, sterilization wraps, mixing tips, dental bibs, and related consumables designed to streamline dental practice workflows and enhance patient care delivery.
Q.I. MEDICAL, INC.
Q.I. Medical manufactures specialized products for pharmacists, nurses, and pharmacy technicians handling sterile solutions. The company focuses on devices, test kits, and accessories that improve aseptic technique and validate compliance with USP Chapters 795, 797, 800, and 71. Product applications include environmental monitoring and surface sampling, gloved fingertip testing, sterility and endotoxin testing, TPN process validation, media fill testing for aseptic technique validation, incubation systems, and needleless dispensing solutions. Q.I. Medical serves institutional pharmacy and compounding operations requiring documented quality assurance and regulatory compliance.
Nutek Bravo
Nutek Bravo is an ISO-certified sterilization and engineering company based in Hayward, California, specializing in electron beam (E-beam) processing for medical device and product sterilization. The company provides a cost-efficient, modern alternative to traditional sterilization methods such as Gamma irradiation and Ethylene Oxide. Services include batch processing, dose mapping, dose audits, dose distribution analysis, process validation, and research & development support. E-beam processing uses high-energy accelerators to deliver precise, validated radiation doses throughout products via controlled scanning technology. The company supports medical equipment manufacturers, healthcare organizations, and research entities with streamlined client onboarding, product qualification, and order fulfillment through a web-based portal.
WHK BioSystems, LLC / Bergman
WHK BioSystems, LLC is a family-owned contract manufacturer based in Clearwater, Florida, established in 2012. The company specializes in single-use process components, assemblies, and consumables for the biopharmaceutical, life science, cell therapy, and medical industries. WHK operates under ISO 13485:2016 certification and FDA registration, utilizing Class 7 cleanroom facilities to ensure high-quality production. The company offers custom single-use products and engineering solutions, including single-use tubing assemblies, bottle and tube assemblies, molded sanitary connectors, and tubing extrusion. Manufacturing capabilities include TPE and silicone injection molding, laser cutting, machining, device assembly, 3D printing, RF welding, and comprehensive packaging services. WHK provides full-spectrum support from initial device design through full-scale production, with a focus on delivering efficient, U.S.-based manufacturing solutions tailored to specialized fluid-handling requirements in bioprocess and cell therapy applications.
Biomerics Mebane
Biomerics is a leading vertically integrated contract development and manufacturing organization (CDMO) specializing in interventional medical devices and components. Established in 1994 and headquartered in Salt Lake City, Utah, the company operates 12 facilities globally across the United States, Ireland, Costa Rica, and the Dominican Republic, employing over 3,200 professionals. The company ranks among the Top 10 interventional CDMOs worldwide and serves 20 of the top 35 medical device OEMs. Biomerics provides end-to-end manufacturing capabilities including design engineering, materials compounding, complex extrusion, micromachining, micro metals processing, and finished device assembly. Core competencies span structural heart, electrophysiology, robotic surgery, endoscopy, and image-guided intervention platforms. The company offers specialized services including polymer and metal fabrication, device packaging, sterilization, and technology transfer. All operations maintain ISO 13485:2016 certification and FDA compliance, with dedicated Centers of Excellence in advanced materials, complex extrusion, and micromachining to support rapid innovation and market delivery.
FLUKE ELECTRONICS CORP.
Fluke Corporation is a leading manufacturer of compact electronic test tools and software for measuring and condition monitoring. Founded in 1948, the company specializes in precision measurement instruments, thermal imaging systems, electrical testing equipment, and calibration tools. Fluke serves technicians, engineers, electricians, and maintenance managers across manufacturing, healthcare, and service sectors with products including digital multimeters, thermal cameras, power quality analyzers, clamp meters, acoustic imaging systems, and industrial ethernet testers. The company also provides calibration management software (CalStudio) and condition monitoring solutions for predictive maintenance and asset management. Fluke's portfolio extends to renewable energy diagnostics (solar panel testing, I-V curve tracers) and electric vehicle supply equipment (EVSE) testing solutions.
Ranfac Corp.
Ranfac Corp. is an ISO 13485:2016-certified Contract Development and Manufacturing Organization (CDMO), Original Equipment Manufacturer (OEM), and Contract Manufacturing Organization (CMO) specializing in custom Class I and Class II single-use hypodermic-based medical devices. Founded in 1888 and based in Avon, Massachusetts, Ranfac operates a vertically integrated 40,000 sq ft facility that manages all production stages in-house: metal machining (12 specialized processes including CNC, laser welding, electropolishing), polymer injection and insert molding (Class 8 cleanroom), cleaning and passivation, cleanroom assembly (Class 7 ISO), and EO sterilization via exclusive STERIS partnership. The company serves minimally invasive surgery access devices, biopsy and aspiration systems, orthobiologics delivery cannulas, interventional radiology components, hematology devices, and general surgery instruments. Ranfac supports low minimum order quantities and scales from prototype to 500K+ units annually. MDSAP, EU MDR, and FDA registered, enabling simultaneous access to seven export markets.
AIKEN MEDICAL SUPPLIES
Medegen Medical Products is a leading manufacturer of disposable medical supplies and patient-care products for hospitals, physician offices, nursing homes, and home health agencies. Part of the Inteplast Group and headquartered in Gallaway, Tennessee, Medegen operates US-based manufacturing facilities in Tennessee and West Virginia. The company specializes in plastic-based medical consumables including patient care items (bedpans, urinals), laboratory supplies (specimen containers), infection control products (protective gowns, masks), biohazard waste containment systems, and autoclavable products. Founded in 1998, Medegen is recognized for quality manufacturing, innovation, and reliable supply chain management serving diverse healthcare settings.
LONG ISLAND STERILIZATION
Long Island Sterilization is a contract sterilization and testing services provider operating since 2001 in Hauppauge, New York. Owned by Busse Hospital Disposables, the company operates a 30,000 sq.ft. facility specializing in ethylene oxide (EO) sterilization and comprehensive validation services for the medical device and disposable industries. Core service offerings include full product EO sterilization, sterilization validation, bioburden testing and reduction, process challenge device (PCD) development, feasibility studies, package validation, transportation studies, ship testing, and accelerated/real-time aging studies. The company provides complete turn-key solutions encompassing design, development, regulatory preparation, and FDA submission support for new medical products. LIS maintains cGMP and FDA-compliant quality assurance systems, with ISO 11135 (sterilization of medical devices) and ISO 10993-7 (ethylene oxide residuals) certifications. The facility includes dedicated EO processing, warehouse, preconditioning, and aeration rooms. The company has processed over 500,000 sterilization cycles and serves medical device manufacturers, contract manufacturers, and medical disposable companies. 24/7 accessibility and expert consulting on EO sterilization processes, bioburden management, and regulatory compliance are standard offerings.
DUERR DENTAL SE
DÜRR DENTAL SE is a German manufacturer of integrated dental practice solutions with over 80 years of industry experience. The company designs and produces compressed air systems, suction units, digital imaging equipment, hygiene products, and prophylaxis systems for dental practices, clinics, universities, and laboratories worldwide. Core product lines include Tornado compressors for compressed air delivery; Tyscor suction systems with Orotol hygiene integration; VistaScan intraoral and VistaPano extraoral digital imaging systems; and Lunos preventive dental care products. The company also offers imaging software solutions including VistaSoft Imaging, VistaSoft Monitor (real-time practice equipment monitoring), and VistaSoft AI Inklusive for diagnostic support. DÜRR DENTAL serves customers across all practice sizes, from solo practitioners to multi-unit dental centers and academic institutions. The company emphasizes system integration, reliability, and innovation in dental diagnostics and practice infrastructure. Manufacturing and service operations span Europe, Asia-Pacific, Latin America, and the Middle East, with headquarters in Bietigheim-Bissingen, Germany. The company provides comprehensive service support including product registration, calibration, maintenance, and ongoing training through their Academy.
MASTERCRAFT DENTAL CO. OF TEXAS
Ross Orthodontic is a family-owned manufacturer and design firm specializing exclusively in orthodontic office environments since 1982. As the only manufacturer dedicated solely to orthodontic equipment and design, Ross has equipped over 1,000 orthodontic practices. The company provides comprehensive office design planning, consulting, and manufacturing of specialized treatment and operational equipment. Products include patient, doctor, and assistant seating; delivery units and cabinets; custom cabinetry; operatory and task lighting (including the ELEF lighting system and Polaris LED task lights); sterilization centers; and mechanical room equipment. All equipment is manufactured with industrial-grade, heavy-duty mechanical components designed for durability and long-term reliability. Ross serves as a single-source supplier for orthodontic office buildouts and renovations, handling design consultation, equipment manufacturing, and direct delivery.
Blue Line Sterilization Services LLC
Blue Line Sterilization Services is an independent ethylene oxide (EO/EtO) contract sterilization provider specializing in rapid, compliant processing for small medical device loads. Founded in 2009 as the first dedicated EO sterilization service for fast turnaround, the company operates 24/7 with 3M Steri-Vac chambers to support medical device manufacturers seeking to minimize time-to-market. Blue Line offers turnkey validation and batch release services, comparative resistance studies, sterilization project management, and support for clinical trials and product launches. FDA-registered and ISO-certified, the company positions itself as the "FedEx of the industry," emphasizing speed, reliability, and responsive customer service. Based in Novato, California, Blue Line partners with dynamic product development programs across the medical device sector and is a founding member of the West Coast Device Alliance (WCDA).
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