Sterilization Equipment in California

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.

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.

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.

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.

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.

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.

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.

Pacific Integrated Manufacturing Inc. is an ISO 13485:2016-certified and FDA-registered contract manufacturer specializing in precision plastic injection molding and assembly services for the life sciences and diagnostics markets. Headquartered in San Diego, California, with a 50,000 sq. ft. production facility in Tijuana, Mexico, the company delivers turnkey manufacturing solutions including injection molding, insert molding, over-molding, tool development, pad printing, ultrasonic welding, and solvent bonding. Core service capabilities encompass custom component manufacturing, product assembly, and comprehensive packaging solutions (kit packaging, bulk packaging, pouch sealing, fill-and-seal, thermoformed trays). The company provides full sterilization validation and processing services, including ETO sterilization, gamma irradiation, and E-beam sterilization, meeting stringent quality requirements for regulated medical device and diagnostics applications. Additional services include order fulfillment, warehousing, and supply chain logistics management. The company serves global life science and diagnostics manufacturers requiring precision plastic components and contract manufacturing with regulatory compliance and traceability.

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.

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 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.

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).

Shanghai Jianzhong Medical Packaging (chinampack.com) is a manufacturer of medical sterilization packaging materials and related consumables founded in 1988. The company specializes in CSSD (Central Sterile Supply Department) products and sterilization packaging solutions for healthcare facilities. With over 35 years of production experience, a workforce of 300 employees, and a daily production capacity of 5 million pouches, the company exports to over 50 countries and is listed on China's NEEQ (National Equities Exchange and Quotations). Product portfolio includes sterilization paper bags, sterilization reels (flat and gusseted, heat-sealed), wrapping sheets, wrapping crepe paper, header bags, aluminum foil bags, middle breath pouches, and indicator tapes for multiple sterilization methods (autoclave steam, ethylene oxide/EO, and plasma). The company also manufactures Bowie & Dick test packs for autoclave validation. Manufacturing capabilities encompass material processing, design, and production of sterilization packaging for both steam and low-temperature sterilization methods. Products are designed to meet international standards for medical device sterilization and are used by hospitals, surgical centers, and sterilization service providers globally.

Jiangsu Conod Medical Devices Co., Ltd. is a Chinese medical device manufacturer and supplier with approximately 20 years of export experience serving over 50 countries across the Americas, European Union, Japan, and developing markets in Asia, Africa, and Latin America. The company manufactures and distributes a broad portfolio of single-use medical consumables and devices across eight primary product categories: urology (catheters, drainage bags, catheterization trays, leg bags, urine meters), personal protective equipment (medical masks, surgical masks, face shields, isolation gowns, examination gloves), wound drainage systems (suction accessories, drainage devices, sputum suction kits), anesthesia and breathing supplies (anesthetic masks, aerosol trays), enteral feeding systems (feeding sets, feeding pumps), household emergency kits, nonwoven fabric materials, and specialty products (enema systems, fecal management collectors). The company operates vertically integrated capabilities including precision mold design and development, in-house injection molding (27 molding machines), third-party sterilization services (ETO sterilization with ISO 11135-2014 and ISO 13485-2016 certifications, FDA and Japanese FMA registration), and independent testing and detection center services. Conod holds Chinese medical device registration certificates and serves domestic and international hospital systems, clinical facilities, and distribution partners. The company emphasizes quality control, advanced manufacturing equipment, and customized product solutions aligned with international regulatory standards.

Star Dental Supply Inc. is a B2B distributor of dental consumables, materials, instruments, and infection control supplies serving dental practices in the US. The company maintains an e-commerce platform (stardentalsupplies.com) offering a comprehensive catalog organized by clinical application areas. Product lines include: impression materials (VPS, alginates, silicone-based systems from manufacturers such as Kulzer, Zhermack, and GC America), bite registration materials, prophy products, preventive materials, rubber dam systems, retraction materials, matrix systems, x-ray accessories and barriers, surgical instruments, waxes, ultrasonic cleaning supplies, and sterilization consumables. Infection control offerings span sterilization pouches (self-seal and nylon varieties), sterilization indicator tape and tubing, barrier films and sleeves, examination and surgical gloves (nitrile and latex-free options), face masks (including N95 respirators and ASTM Level 2/3 surgical masks), and personal protective equipment. The company carries established dental brands including Kerr, Kulzer, Miltex, Hu-Friedy, Bonart, Directa, Parkell, Metrex, Tutnauer, and others. Services include fast shipping, hassle-free returns, quality assurance, and 24/7 customer support. The platform supports both retail and practice-level ordering.

Bioseal is a California-based manufacturer and supplier of sterile, single-use surgical supplies and procedural trays serving healthcare providers for over 35 years. The company specializes in surgical put-ups, single-use instruments, infection control solutions, and custom medical device packaging for Central Sterile Processing Departments and Operating Room Managers. Bioseal offers ISO-certified quality management, OEM custom manufacturing solutions, and products tailored to multiple hospital departments including Emergency, ICU, OR, Cardiology, Labor/Delivery, Orthopedics, and specialty clinics. Key product lines include the Duraholder Instrument Protection System (IPS), BioView Scopes, disposable and custom procedural trays, cast padding, endoscopy kits, and specialized tubing systems. The company maintains group purchasing agreements and serves hospitals nationwide with a focus on reducing patient risk and lowering procurement costs through standardized sterile products and regulatory-compliant sterilization solutions.

Aiken Corporation is a Southern California-based laboratory equipment manufacturer founded in 1988. The company manufactures and exports a comprehensive range of general laboratory equipment using domestic and foreign components, serving hospitals and clinical laboratories in over 60 countries. Product lines include autoclaves, centrifuges, incubators, dry ovens, water and oil baths, biological safety cabinets, microscopes, tissue processors, balances, pH meters, conductivity meters, spectrophotometers, pipettes, refrigerators, and water purification systems. Additional offerings include microtomes, oscillators, polarimeters, clean benches, ultrasonic water baths, water distillers, and PRP (platelet-rich plasma) processing equipment. Aiken provides customer service Monday–Friday, 8:30 am–5 pm PST, including technical support, field service, maintenance, repair, and troubleshooting. The company emphasizes equipment reliability, operational performance, and total cost reduction for laboratory operations. Distribution is global, with manufacturing networks serving domestic and international markets.

M4D LLC is an ISO 13485:2016-certified and FDA-registered medical device manufacturer specializing in the design, development, prototyping, testing, validation, and full-scale manufacturing of endovascular technologies. The company operates three dedicated cleanrooms across 12,000 sq. ft of GMP-compliant facility space, including ISO Class 8 (100K) cleanroom areas. M4D serves as a strategic partner for medical device innovators, providing comprehensive contract manufacturing services from initial concept and design through regulatory compliance and commercialization. With over 70 years of combined industry experience, M4D specializes in complex catheter manufacturing capabilities including catheter winding, marker band swaging, segment fusing, and hydrophilic coating application. The company is committed to quality-driven innovation and maintains rigorous supply chain management and regulatory compliance protocols to support the development of therapies that improve patient outcomes.

SNS Biosystems is a sterilizer monitoring and testing service provider with over 30 years of industry experience. The company specializes in processing and reporting biological indicator testing for steam sterilization validation and implant sterilization verification. Their primary product line is the SNS Biosensor™ biological indicator kits, available in Economy and Premium grades with multiple package sizes (boxes of 12 and 52 units). The company offers routine sterilizer testing services, contract sterilization testing for bulk processing and reporting needs, and implant sterilizer testing with expedited rush service options. SNS Biosystems operates a web-based portal for customer access to test reports and results. The company serves healthcare facilities, surgical centers, and medical device manufacturers requiring sterilization validation and quality assurance documentation.

JMU Dental, Inc. is a professional dental supplier headquartered in Fullerton, California, specializing in competitive pricing and superior customer service for dental practices. The company distributes a comprehensive range of dental equipment, instruments, consumables, and supplies including handpieces, ultrasonic scalers, curing lights, endodontic motors, sterilization pouches, impression materials, and disposable items such as gloves, bibs, and saliva ejectors. JMU also offers dental lab supplies, accessories, and equipment maintenance services. The company operates an e-commerce platform with same-day shipping for orders placed before 3 PM PT and provides online chat and technical support to dental professionals.

Aesthetics Systems USA Inc. is a distributor and retailer of electrolysis equipment, aesthetic machines, probes, skin care products, and professional supplies for esthetic practitioners. The company specializes in electrolysis systems and accessories, including Apilus machines and Pro-Tec, Ballet, and Sterex probes for hair removal. Product lines include electrolysis machines and probes, Action De Gala skin care products (cleansing, moisturizing, and precision care formulations), professional furniture (treatment tables, stools, carts, magnifying lamps), hygiene and infection control supplies (gloves, PPE, disinfectants, sterilization equipment, sharps disposal), waxes and paraffins, and professional clothing and accessories. The company markets itself to esthetic professionals and salons, offering same-day shipping on most orders and positioning itself as a competitive-price distributor. Products are presented as supplies for the electrolysis and esthetic services market rather than clinical medical devices.

Hansfive (Hangzhou) Dental Technology Co., Ltd. is a comprehensive dental solutions provider operating through multiple branded divisions: AORIH (orthodontics), SUYASTAR (clear aligner systems), BORRINCE (dental instruments), and Densten (general products). The company manufactures and distributes a complete range of dental equipment, orthodontic solutions, precision instruments, and oral care disposables for dental clinics and laboratories globally. Product portfolio includes intraoral and lab scanners, dental X-ray systems, dental units, self-ligating and conventional metal brackets, orthodontic springs and archwires, high-precision dental metal instruments, and single-use clinical supplies. Hansfive provides CAD/CAM design solutions and digital orthodontic treatment planning services, enabling practitioners to convert patient scans into customized clear aligner designs and prosthetic restoration plans. The company holds 87 certifications, 30 patents, and maintains 209 global trademarks, indicating substantial investment in quality assurance and intellectual property. Manufacturing capabilities span equipment assembly, precision instrument fabrication, and consumables production. The company serves dental practitioners, technicians, and laboratories across multiple continents with a focus on clinical efficiency, safety, and procedural outcomes.

Centerpiece Holdings LLC is a contract manufacturing and ETO sterilization services provider specializing in medical device supply chain solutions. The company operates a world-class ethylene oxide (ETO) sterilization facility in Tijuana, Mexico, with ten processing chambers, twelve aeration cells, and three large aeration rooms capable of high and low-volume processing. They provide integrated services including product and packaging design, design-for-manufacturability (DFM), sterilization compatibility analysis, contract manufacturing of Class II and III devices in certified Class 8 clean rooms, contract packaging (including bar sealing, tray sealing, custom form-fill-sealing, and foil flow wrapping), and sterile product warehousing with ambient and heated aeration capabilities. Centerpiece is FDA registered and ISO 13485 certified. Their manufacturing and sterilization operations are strategically located near the US-Mexico border, approximately 15 minutes from the US border, providing efficient logistics for North America's largest medical device manufacturing region. The company positions itself as a full-supply-chain solution provider rather than a standalone contract manufacturer, offering linked services that accelerate product innovation and commercialization from design through post-sterilization storage.

Top Quality Manufacturing is a distributor and supplier of medical examination gloves, infection control consumables, and dental supplies. The company offers a diverse portfolio of disposable gloves including nitrile, latex, and polychloroprene variants under proprietary brand lines such as 2nd Skin, BioGrip, TruGrip, FreeHand, Jeannie, Smile, and Periwinkle Pink. Products are available in multiple colors (black, blue, pink, white, green, violet) and box counts ranging from 100 to 300 units. Beyond gloves, Top Quality Manufacturing stocks sterilization pouches, infection control consumables (face masks ASTM Level 3), dental bibs (2-ply), headrest covers, and a curated selection of dental products including impression materials, evacuation systems, anesthetics, and restorative materials from partners such as Parkell Inc. The company serves dental practices and medical facilities with emphasis on same-day shipping and bulk order fulfillment. Products are marketed as budget-friendly essentials for clinical environments. While specific regulatory certifications are not detailed on the homepage, the product range suggests compliance with standards applicable to medical examination gloves and sterilization consumables. The company operates a B2C e-commerce platform alongside B2B ordering capabilities.

Prism Pacific Industries manufactures and services safe patient handling equipment for hospitals, long-term care facilities, and home healthcare settings. The company specializes in two primary product lines: reusable medical lifting, transfer, and mobility devices (lateral transfer mats, repositioning sheets, high-back seated slings) designed for repeated use with proper cleaning and disinfection, and single-use safe patient handling equipment for one-time applications where infection prevention is critical. Additionally, Prism Pacific operates a single-use medical device reprocessing service that cleans, sterilizes, tests, and repackages medical devices originally manufactured for single use, extending their utility and reducing facility costs. The company holds ISO 13485:2016 certification and maintains ANSI National Accreditation under ISO/IEC 17021-1, reflecting commitment to quality management systems and patient safety standards. Prism Pacific serves healthcare providers requiring cost-effective, sustainable alternatives to disposable patient handling equipment without compromising safety or infection control protocols.