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Wound Care Manufacturers

Last updated: January 2026

This directory lists 107 wound care manufacturers across the United States, from custom hydrocolloid formulation specialists to high-volume foam dressing converters.

Buyers leverage these manufacturers to solve critical problems such as scaling intricate advanced wound dressing designs, ensuring precise exudate management capabilities for novel products, or obtaining specialized adhesive lamination for multi-layer wound contact materials. They are essential partners for navigating the complexities of U.S. FDA 510(k) submissions and ensuring adherence to ISO 13485 standards throughout the product lifecycle.

Supplier types in this space range significantly, encompassing full-service contract manufacturers that handle everything from material sourcing to final packaging and sterilization, to specialized converters focused solely on specific processes like die-cutting, slitting, or sterile barrier system assembly. Some manufacturers excel in specific material classes, such as silicone-based foam dressings, while others offer broad capabilities across various wound contact layers and securement solutions.

To engage effectively, buyers should come prepared with detailed product specifications including material composition, desired moisture vapor transmission rate (MVTR) values, proposed sterilization method, packaging requirements, and target cost. Manufacturers expect comprehensive design for manufacturability (DFM) feedback and a clear understanding of the intended use and regulatory classification (e.g., Class I, II, or III) of the wound care device.

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Company Directory

107 companies nationwide

AlexiGen

San Antonio, TX

AlexiGen, based in San Antonio, TX, specializes in providing high-quality biologics for wound care, surgical, and sports medicine applications. The company adheres to strict policies in donor screening and tissue recovery, striving to deliver innovative solutions and superior customer service nationally.

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AMERIGEL Advanced Skin & Wound Care

Oldsmar, FL

Based in Oldsmar, FL, AMERIGEL Advanced Skin & Wound Care manufactures a line of products designed for wound healing and skin protection. Their offerings include hydrogel wound dressings, saline wound wash, bordered gauze dressings, and lotions to treat conditions like ulcers, burns, and dry skin breakdown.

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AMERX Health Care

Oldsmar, FL

AMERX Health Care manufactures a comprehensive range of advanced skin and wound care products. Offerings include physician-rated hydrogels, bioactive collagen, wound care kits, and dressings. The company also provides compression garments and a Turn-Key DME Wound Care Program, supporting effective wound healing and reduced scarring.

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Amparo Medical Technologies

Anaheim, CA

Based in Anaheim, CA, Amparo Medical Technologies is an ISO 13485:2016 certified manufacturer specializing in custom hydrocolloid medical grade adhesives. The company formulates and produces master rolls for diverse applications, including wound care, ostomy, device attachment, and cosmetics.

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Amsino International, Inc

Pomona, CA

Amsino International, Inc. manufactures a range of medical devices, including AMSure® products specifically designed for wound irrigation. Their portfolio also encompasses IV infusion, medication delivery systems, and enteral feeding solutions for healthcare facilities. Based in Pomona, CA, the company provides comprehensive medical device solutions.

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Advanced Oxygen Therapy Inc.

Oceanside, CA

Based in Oceanside, CA, Advanced Oxygen Therapy Inc. manufactures the TWO2 multi-modality topical wound oxygen therapy. This system delivers high-pressure O2, non-contact cyclical compression, and humidification to promote durable healing of acute and chronic wounds. Clinically proven, TWO2 reduces DFU recurrence, hospitalizations, and amputations.

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Arch Therapeutics, Inc.

Based in Framingham, MA, Arch Therapeutics is a biotechnology company developing and marketing advanced wound care products. They utilize a novel self-assembling barrier technology platform to stop bleeding, control leaking, and manage wounds during surgery, trauma, and interventional care, including the AC5 Advanced Wound System.

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AVITA Medical, Inc.

AVITA Medical, Inc. provides innovative, therapeutic acute wound care technologies. Specializing in optimized healing and accelerated patient recovery, their platform includes the FDA-approved RECELL® System for thermal burns and full-thickness skin defects. They also offer PermeaDerm® and Cohealyx™ dermal matrices.

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Hartmann USA

Doral, FL

Based in Doral, FL, Hartmann USA manufactures a comprehensive range of compression and wound management products. Their offerings are designed for treating conditions like lymphedema, edema, and various other medical needs, primarily serving the healthcare sector.

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BD

BD is a global medical technology company developing, manufacturing, and selling a broad range of medical devices and solutions. This includes the BD Surgiphor™ Antimicrobial Irrigation System, a ready-to-use lavage solution designed for mechanical debris removal and wound cleansing.

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BioLab Holdings, Inc.

Mesa, AZ

Based in Mesa, AZ, BioLab Holdings, Inc. specializes in advanced wound care solutions, leveraging science and innovation. The company manufactures and refines a portfolio of skin substitute products, including Membrane Wrap - Lite™, Membrane Wrap™, and Microlyte® SAM™, to support providers and patients with effective treatment options.

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BioStem Technologies, Inc.

Fort Lauderdale, FL

Based in Fort Lauderdale, FL, BioStem Technologies, Inc. manufactures perinatal tissue allografts for regenerative therapies. The company utilizes its proprietary BioREtain® method to preserve biological properties and structure. Their products, including skin substitutes, support improved healing for chronic wounds.

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Biowound Solutions

Biowound Solutions manufactures advanced dressings and collagen technologies for comprehensive wound management. They develop innovative solutions to meet evolving demands in wound care, specifically supporting processes like granulation.

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Bravida Medical

Geneva, IL

Based in Geneva, IL, Bravida Medical specializes in manufacturing transformative wound care and infection prevention products. Their portfolio includes Anasept, an FDA-cleared broad-spectrum antimicrobial cleanser, gel, and irrigation solution, alongside innovative silver-plated wound dressings that deliver antimicrobial benefits without staining or increasing bioburden.

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BRIJ Medical

Marietta, GA

Based in Marietta, GA, BRIJ Medical develops revolutionary technologies for post-surgical wound care, specializing in closure, support, and scar therapy. Their flagship product, BRIJJIT, is a force-modulating tissue bridge that reduces tension around incisions, promoting less wound breakdown and superior scar outcomes.

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Calmoseptine, Inc.

Huntington Beach, CA

Calmoseptine, Inc. manufactures Calmoseptine Ointment, a multipurpose moisture barrier product designed to protect, soothe, and promote healing. This pharmacist-recommended brand specializes in incontinence-related skin protectants, offering a solution for skin integrity and wound care.

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CellEra, LLC

Monroe, OH

Based in Monroe, OH, CellEra, LLC is a healthcare products company focusing on long-term care. They provide a range of branded wound care products, including Vitále, PeleVerus, and Array & Afresh lines. CellEra designs and ships its products directly to facilities and patients nationwide.

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Convatec

Oklahoma City, OK

Based in Oklahoma City, OK, Convatec is a global medical products and technologies company. It develops and produces advanced wound care solutions for managing hard-to-heal wounds and preventing wound occurrence. Convatec also offers therapies for ostomy care, continence care, and infusion care.

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Cork Medical, LLC

Indianapolis, IN

Based in Indianapolis, IN, Cork Medical, LLC manufactures innovative medical devices for wound care, including negative pressure wound therapy (NPWT) systems like the Nisus One. They also provide support surfaces, specialty mattresses, and wheelchair cushions to enhance patient recovery.

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Corza Medical

Boulder, CO

Based in Boulder, CO, Corza Medical manufactures a range of wound closure devices and related surgical solutions. The company provides essential products for healthcare professionals, with offerings spanning biomedical textiles, biosurgery, ophthalmology, and wound care. Their focus is on delivering critical tools for surgical procedures and post-operative closure.

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Cutimed Wound Care

Charlotte, NC

Cutimed Wound Care, based in Charlotte, NC, manufactures advanced products for comprehensive wound management. They provide solutions for thorough wound cleansing, debridement, and effective infection control. Utilizing technologies such as Sorbact®, their offerings address antimicrobial resistance and promote successful wound healing outcomes.

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DermaClip

Houston, TX

DermaClip, based in Houston, TX, specializes in manufacturing innovative, non-invasive skin closure devices. They provide needle-free wound closure solutions for medical professionals, military applications, and personal use, optimizing wound care with simple, quick, and tension-free techniques in various settings.

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DermaMed Coatings

Tallmadge, OH

Based in Tallmadge, OH, DermaMed Coatings manufactures pressure-sensitive adhesive medical tapes for diverse healthcare applications, including wound care, surgical disposables, and wearables. The ISO 13485 certified company provides expertise in product customization, testing, and laminating solutions, offering specialized adhesive materials with stringent quality controls.

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DeRoyal

DeRoyal is a global medical manufacturer established in 1973, specializing in OEM product manufacturing. They produce transparent, semi-occlusive, breathable polyurethane wound dressings suitable as primary or secondary dressings for non-draining wounds, and also provide sterilization services.

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EnColl Corporation

Fremont, CA

Based in Fremont, CA, EnColl Corporation develops and manufactures high-purity Type-I collagen products using its patented Two-step enzyme Treatment Process. They produce Helicoll®, a bioengineered acellular skin substitute designed to enhance tissue generation and support wound management. EnColl's collagen is intended for diverse medical applications.

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Engineered Tissue Solutions

Rolla, MO

Based in Rolla, MO, Engineered Tissue Solutions manufactures a unique borate-based bioactive glass fiber matrix. Their Mirragen® product facilitates quality tissue formation and reduces infection risk for chronic and surgical wound care, offering an easy-to-use, versatile solution. All innovation and manufacturing are performed in the United States.

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ENLUXTRA

Santa Clara, CA

Based in Santa Clara, CA, ENLUXTRA manufactures a proprietary smart wound dressing. This self-regulating, moisture-balancing fiber dressing offers high absorbency, adaptive hydration, and effective autolytic debridement support. It is designed for various wound types, including diabetic, venous, postoperative, and radiation burns.

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Extricare

Extricare manufactures advanced wound care technologies, focusing on improving patient outcomes, clinician efficiency, and reducing healthcare costs. The company specializes in Negative Pressure Wound Therapy (NPWT) products, including the extriCARE 1000, 3000, and 3600 systems. They develop innovative medical devices for the wound care industry.

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First Aid 2000

First Aid 2000 manufactures burn care kits, specializing in products for minor burns. The company produces water-based gels and sprays designed to alleviate rapid and ongoing pain. These offerings make First Aid 2000 a direct provider of wound care solutions.

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Halyard Health

Halyard Health delivers advanced wound care solutions, featuring high-performance silicone foam and gelling fiber dressings, designed to support optimal healing. The company provides healthcare facilities with products and protocols for patient safety, infection control, and operational efficiency, assisting with various healthcare complexities.

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Harbor MedTech, Inc.

Harbor MedTech, Inc. is a regenerative medicine company focused on advanced orthopedic soft tissue repair and wound healing solutions. Their patented BriDGE® technology transforms collagen into a matrix that accelerates healing, supports tissue regeneration, and limits scar tissue formation. With FDA-cleared products, they address chronic skin wounds and various surgical repairs.

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Healwell Biologics

Beverly Hills, CA

Healwell Biologics specializes in manufacturing innovative amniotic membrane grafts and advanced wound care products. Based in Beverly Hills, CA, the company provides cutting-edge solutions for healthcare professionals. Their products are designed to optimize patient healing and expedite the recovery process for various types of wounds.

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Hi-Tech Products

Buena Park, CA

Based in Buena Park, CA, Hi-Tech Products specializes in precision and rotary die cutting, converting, assembly, and packaging services. They are a Negative Pressure Wound Therapy (NPWT) dressing manufacturer, offering multiple certified cleanrooms. The company holds ISO 9001:2015 and ISO 13485:2016 certifications for manufacturing complex engineered components.

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Imbed Biosciences

Madison, WI

Imbed Biosciences is a privately held biotech company based in Madison, WI, specializing in advanced biomaterials for wound care. They develop and manufacture FDA-cleared and investigational medical devices, including MicroLyte® Matrix and PainGuard™, for managing hard-to-heal wounds. Their innovative solutions help address infection risk and pain.

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Irrisept

Lawrenceville, GA

Based in Lawrenceville, GA, Irrisept (Irrimax Corporation) develops antimicrobial wound lavage solutions. Their Irrisept product contains CHG as a preservative, offering broad-spectrum activity against microorganisms. It provides low-pressure irrigation to remove debris and contaminants from wounds, crucial for bioburden reduction.

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Leukoplast

Leukoplast provides comprehensive wound care solutions, addressing cleansing, absorption, protection, securing, and various wound dressings. Their product range is designed to safeguard patients during surgery and supports diverse applications in sports medicine. They offer essential supplies and solutions for medical professionals.

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Life Biologics

Life Biologics specializes in manufacturing advanced human amniotic tissue grafts and skin substitutes. They transform placental tissue into high-quality biologics for cutting-edge wound care treatments, focusing on enhancing tissue regeneration and reducing infection risk. The company also offers reimbursement support and educational resources.

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LifeNet Health

Virginia Beach, VA

Based in Virginia Beach, VA, LifeNet Health provides regenerative wound solutions to support patient healing. They manufacture and offer a portfolio of advanced products, including Dermacell® Porous, for comprehensive wound management from debridement to closure, leveraging innovative human cell- and tissue-based technologies.

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LifeScience PLUS Inc.

Phoenix, AZ

LifeScience PLUS Inc. based in Phoenix, AZ, develops and manufactures innovative total wound care solutions. They offer advanced products for hemostasis (bleeding control), sealants, and moist dressings. Their patented BloodSTOP® iX, a plant-based hemostatic matrix, effectively treats acute and chronic wounds.

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L&R USA INC.

L&R USA INC. manufactures advanced wound care solutions, including therapeutic Debrisoft monofilament devices for chronic wound management. As part of the Lohmann & Rauscher Group, they also supply custom procedure packs, disposable surgical products, and surgical instruments, serving a broad spectrum of operating room needs.

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MicroMend Skin Closure

Seattle, WA

Based in Seattle, WA, MicroMend Skin Closure manufactures revolutionary wound closure devices. Their products work faster than sutures, offering painless application and removal without scarring. Utilizing a dual-action system of Microstaples and Cantilever Springs, MicroMend serves healthcare professionals and consumers.

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MPM Medical

Mesquite, TX

MPM Medical develops and distributes innovative advanced wound care products, including antibacterial surgical collagens, lidocaine hydrogels, and super absorbent dressings like ExcelSAP™. They specialize in solutions for chronic wounds and are launching TriSAP, a novel silicone, silver, and super absorbent dressing, in 2025.

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NEXGEL, Inc.

NEXGEL, Inc. is an FDA registered and ISO certified cGMP manufacturing facility. Specializing in hydrogel platform technology, they produce gentle patches for wound healing and care, OTC medications, and custom product applications. These versatile hydrogels can be formulated with or without active ingredients.

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NuMed Industries

Delray Beach, FL

Based in Delray Beach, FL, NuMed Industries is a manufacturing company specializing in Advanced Wound Care products. They produce a range of quality products including foams, hydrocolloids, hydrogels, composite dressings, calcium alginates, silver alginates, collagens, and silicones.

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Oleeva

Based in Allentown, PA, Oleeva manufactures advanced silicone scar treatments for preventing new scars and reducing existing ones. Their latex- and drug-free products are made in an FDA-approved facility in the USA, utilizing Silon® Technology to offer a non-messy solution for wound and scar care.

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Omeza

Sarasota, FL

Based in Sarasota, FL, Omeza manufactures OCM™ wound matrix, a novel drug-device combination product. It provides comprehensive, multimodal therapy for all phases of wound healing and reduces biofilm. This proprietary technology addresses issues common to chronic wounds and is administered by healthcare professionals.

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Coloplast Corp

Minneapolis, MN

Based in Minneapolis, MN, Coloplast Corp. manufactures a wide range of high-quality wound care solutions. They support the management of diverse wounds, from non-infected to infected. The company also offers innovative medical devices for ostomy and continence care.

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ProgenaCare Global

ProgenaCare Global specializes in advanced wound care products, featuring their unique Human Keratin Matrix, ProgenaMatrix. This human-centered approach provides solutions for chronic wounds, such as diabetic ulcers, by leveraging human keratin. Their antimicrobial wound gel further aids healing by preventing infection, focusing on improving patient outcomes.

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pure&clean

Nixa, MO

Based in Nixa, MO, pure&clean specializes in manufacturing hypochlorous acid (HOCl) solutions for advanced wound care. They supply a range of products including HOCL wound disinfectant, lavage solutions, wound bed preparation, and irrigation solutions. Their offerings encompass HOCI Hydrogel and HOCI Wound Cleanser, designed for effective wound management.

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Rapid Nexus Nanotech Wound Solutions, Inc.

Brea, CA

Rapid Nexus Nanotech Wound Solutions, Inc. based in Brea, CA, develops regenerative medical devices for chronic wounds. Its patented therapeutic system targets root causes by restoring nerve function and circulation. This technology prevents amputations and supports recovery for patients with diabetes, trauma, and peripheral vascular disease.

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Royal Biologics Inc.

Hackensack, NJ

Based in Hackensack, NJ, Royal Biologics Inc. develops and manufactures orthobiologic and life science solutions focused on enhancing healing. The company provides innovative wound care and biologic products, leveraging autologous and live cellular therapies to address musculoskeletal and regenerative medicine challenges through a comprehensive product portfolio.

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Sanara MedTech Inc.

Fort Worth, TX

Based in Fort Worth, TX, Sanara MedTech Inc. is a medical technology company focused on developing and commercializing advanced healing solutions. They provide transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical and skin markets.

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SANUWAVE Health, Inc.

Eden Prairie, MN

Based in Eden Prairie, MN, Sanuwave Health, Inc. develops and manufactures the UltraMIST® System, an FDA-cleared ultrasound device. This innovative technology delivers pain-free saline mist to restore the body’s regenerative process, offering an advanced solution for faster wound healing.

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SigmaGraft Biomaterials, Inc.

Fullerton, CA

Based in Fullerton, CA, SigmaGraft Biomaterials, Inc. manufactures high-quality biomaterials for dental and orthopedic applications. They specialize in products for bone and tissue regeneration, including bone substitutes, resorbable membranes, and specific wound dressings like SigmaPlug™ and SigmaTape™, improving patient outcomes in various surgical procedures.

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Silagen

Northbrook, IL

Silagen manufactures physician-exclusive medical-grade silicone scar therapies and skin repair treatments. Their comprehensive line includes topical silicone gels, sheeting, and shapes designed for post-procedure recovery, effectively managing scars, bruising, and swelling after surgery or other skin trauma.

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Bio Med Sciences

Based in Allentown, PA, Bio Med Sciences manufactures innovative scar management products under its Silon brand. The company develops solutions designed to reduce and prevent scars, serving medical professionals and consumers. Bio Med Sciences provides comprehensive approaches to improve skin healing and appearance, making it a relevant provider for wound care product needs.

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Smith+Nephew

Smith+Nephew is a medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company provides advanced wound management solutions, alongside offerings in orthopaedics, sports medicine, and ENT, utilizing technology to restore patient function.

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Solventum

Solventum, a standalone company, provides evidence-based solutions for enhanced wound healing. Spun off from 3M's healthcare business, they offer a wide range of negative pressure wound therapy products, including their V.A.C.® Therapy. The company manufactures solutions designed to support and promote healing.

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Spartronics

Strongsville, OH

Spartronics provides FDA-registered contract manufacturing services specializing in electronic assemblies, subsystem integration, and full-box builds for medical devices and life science products. Their Strongsville, OH facility focuses on highly-regulated, complex product manufacturing. They serve global customers in mission-critical vertical markets.

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SUTUREGARD Medical, Inc.

Corvallis, OR

Based in Corvallis, OR, SUTUREGARD Medical, Inc. manufactures the SUTUREGARD Adhesive Suture Retention Device (ASRD). This innovative device transforms surgical wound management, offering superior performance in high-tension wounds and post-surgical edema. It minimizes complications, ensures optimal wound healing, and is clinically proven to prevent and manage wound dehiscence.

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Swiss American CDMO

Carrollton, TX

Based in Carrollton, TX, Swiss American CDMO is a full-service Contract Development & Manufacturing Organization. They develop and manufacture topical skin and wound care products for brands worldwide. With over 35 years of experience, the company offers comprehensive solutions from discovery and innovation to commercialization.

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Sylke, Inc.

La Jolla, CA

Based in La Jolla, CA, Sylke, Inc. manufactures SYLKE® Adhesive Wound Closure, a U.S. FDA Class I medical device. These innovative products feature silk fibroin and a medical-grade adhesive, providing biocompatibility, breathability, and water-resistance for secure skin approximation. Designed without cyanoacrylates, they can be worn for up to two weeks.

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The Starco Group

Vernon, CA

The Starco Group is a contract manufacturer specializing in innovative material formulation for consumer and industrial products. They produce personal care FDA and OTC products, including alcohol-based items, mineral and plant-based sunscreens, and sunburn relief. The company offers end-to-end solutions and private labeling opportunities across multiple consumer categories.

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Tides Medical

Lafayette, LA

Based in Lafayette, LA, Tides Medical manufactures high-quality human amniotic tissue grafts, creating advanced skin substitutes for wound care. The company acquires and processes donated placentas in-house, utilizing an ISO Class 6 Cleanroom and terminal radiation sterilization. They operate in compliance with FDA guidance and AATB standards, focusing on patient access.

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Tiger Wound Care, LLC

Tiger Wound Care, LLC advances wound care through innovative, science-driven tissue technologies. The company develops allografts utilizing placental tissue and amniotic membranes, focusing on Cellular, Accellular, and Matrix-like Products (CAMPs). These products support tissue regeneration, promote repair, and address diverse wound care needs.

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Tricol Biomedical

Portland, OR

Tricol Biomedical is a medical device company based in Portland, OR, dedicated to advancing hemostatic and wound care management. They develop innovative products, including the HemCon line, utilizing proprietary Chito+™ technology to control bleeding and support wound healing across trauma, procedural, and consumer self-care markets.

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Urgo Medical North America

Fort Worth, TX

Urgo Medical North America develops and supplies medical devices and products for the care and management of wounds, skin, and skin breakdown. Serving hospitals, nursing homes, and home health agencies in the US, their portfolio includes wound cleansers, advanced dressings, and compression systems.

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Vomaris

Naples, FL

Vomaris, based in Naples, FL, manufactures innovative wound care and infection control products. Their proprietary bioelectric V.DOX Technology bandages prevent bacterial and biofilm infections, promoting faster healing and reduced scarring. These advanced products offer antibiotic-free solutions for chronic wounds.

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Wound Care Systems

Plano, TX

Based in Plano, TX, Wound Care Systems manufactures the FDA-cleared Pulsar II™ Selective Hydro-Mechanical Debridement System. This device delivers 15Psi of optimal pressure to remove bio-load from chronic and acute wounds, including pressure injuries, various ulcers, and burns. It offers portable, disposable, and pain-free wound cleansing.

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Zimmer Biomet

Warsaw, IN

Zimmer Biomet manufactures wound care debridement systems, including Pulsavac Plus and Pulsavac Plus AC, providing versatile solutions for wound irrigation and suction cleaning. The company also specializes in a wide range of medical devices focused on improving mobility and joint health.

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Advamedica Inc.

Based in Cambridge, MA, Advamedica Inc. develops novel biomaterial-based hemostatic, surgical, and wound care products. They specialize in chitosan-based dressings, including Maxiocel, an advanced wound care dressing with USFDA 510(k) clearance, and Axiostat Gauze for managing bleeding wounds.

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Auxilium Health, Inc.

Auxilium Health, Inc. develops advanced biomaterials designed to enhance wound healing. The company focuses on integrating therapeutic and diagnostic benefits to provide smarter solutions for patient care, aiming to improve healing outcomes one patient at a time.

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Burnshield USA

Brooklyn, NY

Burnshield USA specializes in manufacturing a sterile line of burn gels and dressings, designed for optimal emergency burn-care. Their products, including gels, dressings, vests, and kits, serve emergency first responders, industrial clients, and home first aid needs.

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GelSana Therapeutics, Inc.

Aurora, CO

Based in Aurora, CO, GelSana Therapeutics, Inc. develops highly elastic wound dressings through proprietary polymer chemistry. These innovative biomaterial dressings conform to wounds, aiming to reduce inflammation, prevent infection, and provide sustained drug delivery. They offer advanced solutions for various wound healing needs, including chronic wounds.

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Guard Medical

Miami, FL

Guard Medical, based in Miami, FL, manufactures innovative negative pressure wound therapy (NPWT) products. Their flagship, NPseal, is a simple, easy-to-use dressing designed to promote wound healing for surgical patients. NPseal aims to lower the complexity and cost of traditional NPWT, facilitating patient recovery at home.

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Integra LifeSciences

Integra LifeSciences develops and manufactures versatile, evidence-based regenerative technologies for soft tissue reconstruction. Their solutions are designed to treat, repair, and protect patients with acute and chronic complex wounds and burns, including advanced solutions for plastic and reconstructive surgery and nerve and tendon repair.

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Mar-Med

Grand Rapids, MI

Based in Grand Rapids, MI, Mar-Med manufactures specialized irrigation shields designed for wound care applications. Their products facilitate optimal pressure and complete splash protection, enhancing the safety and efficiency of wound irrigation procedures. Mar-Med focuses on providing effective solutions for healthcare professionals.

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Medical Z

Houston, TX

Based in Houston, TX, Medical Z manufactures advanced compression garments primarily for burn care and post-operative recovery. They also produce innovative scar management gels, offering crucial solutions for wound healing and scar prevention. Serving healthcare professionals, the company provides custom-fit products for diverse medical needs globally.

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MediWound

MediWound develops next-generation enzymatic treatments for non-surgical tissue repair, focusing on solutions for burns and chronic wounds. As a biotechnology company, they provide products like NexoBrid® for severe burns and EscharEx® for hard-to-heal wounds, aiming to accelerate healing and improve patient outcomes.

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Medtronic

Medtronic manufactures a comprehensive portfolio of wound care and wound closure products. These medical devices include sutures, needles, hemostats, and topical skin adhesives, as well as surgical staplers. The company provides essential tools for surgical and post-operative wound management.

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Ferris Mfg. Corp.

Fort Worth, TX

Based in Fort Worth, TX, Ferris Mfg. Corp. manufactures PolyMem dressings for advanced wound care. These unique dressings control inflammation, reduce pain, and enhance healing by continuously cleansing and debriding the wound bed. PolyMem products feature a hydrophilic matrix with a cleanser, moisturizer, and superabsorbent.

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Stryker

Weston, FL

Based in Weston, FL, Stryker is a global medical technology company that manufactures innovative products for wound care. This includes non-invasive skin closure devices, such as the Zip, which are engineered for surgical incisions and lacerations to distribute strain effectively.

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Acera Surgical Inc.

St. Louis, MO

Based in St. Louis, MO, Acera Surgical Inc. is a bioscience company specializing in regenerative medicine. They develop and commercialize fully engineered materials, including advanced dermal matrices, to promote faster, stronger tissue repair. Their innovative products are utilized for a wide range of wound care applications like burns, diabetic foot ulcers, and surgical wounds.

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Applied Biologics

Applied Biologics specializes in manufacturing a range of wound care products. All products are exclusively made in the USA and supplied to wound care centers nationwide. The company provides proven products combined with comprehensive clinical support to assist healthcare providers.

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Areza Medical

Dallas, TX

Areza Medical provides a comprehensive range of professional-grade wound care and scar management products. Their extensive catalog includes various wound dressings like alginate, hydrogel, foam, and silver-containing options. The company also offers preventative dressings and silicone gel sheets for scar reduction, supporting healing and preventing complications.

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Axiom Medical, Inc.

Torrance, CA

Based in Torrance, CA, Axiom Medical, Inc. is a woman-owned manufacturer and distributor of silicone extruded wound drains. Established in 1976, the company provides FDA-registered, MDSAP/ISO 13485 certified products made entirely in the USA. Axiom Medical specializes in original full silicone lines for post-operative wound care, often conceptualized by surgeons.

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Baxter

Baxter manufactures Floseal, an advanced adjunct hemostatic agent for effective bleeding control. This proprietary solution combines two independent hemostatic components, proven across a wide range of bleeding scenarios to support wound management and surgical procedures.

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Biodermis

Birmingham, MI

Based in Birmingham, MI, Biodermis manufactures advanced wound and scar care solutions. The company provides silicone-based topical products like BIOCORNEUM® SiliSilk™ and SiliShield® for optimal scar outcomes and bruise recovery. They also offer Epi-Derm for post-surgical healing and Epifoam compression foam.

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DermaRite

DermaRite specializes in manufacturing hydrogel wound care products for commercial clients. They provide a diverse range of wound care solutions specifically designed for elder care centers. Products are available in bulk quantities, catering to institutional needs and ensuring reliable supply.

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Essity USA

Essity USA, based in Philadelphia, PA, is a global manufacturer of hygiene and health products. Through the 1975 acquisition of Mölnlycke, a medical solutions company, Essity's manufacturing capabilities include specialized wound care applications.

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Evergen

West Lafayette, IN

Evergen is a Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine therapies. The company partners with innovators to develop and produce customized solutions for various clinical areas, including plastic and reconstructive surgery, sports medicine, and orthopedics, supporting advanced wound care needs.

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ExtremityCare

ExtremityCare manufactures cell and tissue technologies supporting tissue repair and reconstruction. They provide placental tissue, xenograft tissue, and acellular dermis for wound care applications. Their carePATCH™ Dual Layer Amniotic Membrane allograft offers a protective barrier, aiding in the management of acute and chronic wounds.

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Hydrofera Blue

Hydrofera Blue manufactures advanced foam dressings for wound care professionals. Their products, including Ready-Border dressings, feature gentle silicone adhesive borders for atraumatic changes. Utilizing non-cytotoxic antibacterial foam, these dressings ensure intimate contact for effective wound management solutions.

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medi USA

Whitsett, NC

medi USA is a medical device manufacturer specializing in compression therapy products for venous and lymphatic diseases. The company provides innovative solutions, including the mediven® ulcer kit, for the treatment and management of venous leg ulcers and related conditions.

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Merryweather Foam

Barberton, OH

Merryweather Foam manufactures custom foam products, including silicone foam specifically for wound dressings. Their foam is designed to facilitate moist healing environments and allow for pain-free removal. Serving the medical industry, they offer diverse manufacturing capabilities such as CNC cutting, die cutting, and adhesive lamination from multiple US facilities.

Phone available

Pensar Medical

Scottsdale, AZ

Pensar Medical, headquartered in Scottsdale, AZ, is a medical device manufacturer specializing in Negative Pressure Wound Therapy (NPWT) systems. They design and produce advanced wound care dressings and related treatment equipment, catering to healthcare providers. The company focuses on developing innovative solutions for effective wound healing management.

Phone available

R&D Medical Products

Lake Forest, CA

Based in Lake Forest, CA, R&D Medical Products is a direct manufacturer of wound care solutions. They specialize in producing a variety of products, including wound care gels, hydrogels, and transdermal patches, all made in their California facility. The company also manufactures hypochlorous acid for medical applications.

Phone available

RenovoDerm

Dublin, OH

Based in Dublin, OH, RenovoDerm manufactures advanced synthetic, bioabsorbable wound care products. Their Phoenix and Anthem wound matrices mimic the extracellular matrix, promoting rapid healing and native tissue regeneration. Designed to mitigate scar formation, these innovative products contain no human or animal tissue, eliminating associated risks.

Phone available

Scapa Healthcare

Knoxville, TN

Based in Knoxville, TN, Scapa Healthcare designs and manufactures proprietary hydrocolloids and skin-friendly topical solutions for advanced wound care. They serve as a strategic outsource partner, developing and producing innovative medical device fixation products for global medtech and consumer wellness companies.

Phone available

Stability Biologics

San Antonio, TX

Based in San Antonio, TX, Stability Biologics is a regenerative medicine company that manufactures advanced biologic products. They provide high-quality, ethically sourced human tissue products for wound, surgical, burn, and bone applications, focusing on enhancing patient outcomes.

Phone available

UFP MedTech

UFP MedTech specializes in manufacturing custom negative pressure wound therapy (NPWT) solutions and single-use medical devices. They provide full-service design, development, engineering, and production, leveraging advanced medical-grade foams and materials. The company supports clients from concept through manufacturing at its US facilities.

Phone available

3M

3M is a global manufacturing company specializing in diverse product lines, including healthcare solutions. They directly produce advanced wound care products like specialized dressings. These dressings incorporate gel-forming agents that activate with wound exudate, creating a moist environment conducive to healing and patient recovery.

No contact on file

Organogenesis

Based in Canton, MA, Organogenesis manufactures Apligraf, a bioengineered skin substitute utilizing living cells. This product is designed to transform chronic wounds, including venous leg ulcers and diabetic foot ulcers, by accelerating the healing process.

No contact on file

FXI

Based in Radnor, PA, FXI manufactures engineered medical and comfort solutions for the healthcare sector. The company utilizes patented Surface Modification Technology (SMT) to provide high levels of pressure redistribution. This technology is critical for significantly reducing risk and supporting wound prevention, improving patient outcomes with specialized products.

No contact on file

J&J MedTech

New Brunswick, NJ

J&J MedTech, operating through its Ethicon brand, specializes in manufacturing advanced wound closure products. These medical devices are engineered to improve patient outcomes, optimize healing processes, and enhance operating room efficiency for healthcare professionals.

No contact on file

Medline

Northfield, IL

Based in Northfield, IL, Medline manufactures a comprehensive portfolio of advanced wound care solutions. Their offerings include a range of wound dressings, debridement products, and cleansers designed to promote the healing process for healthcare providers and patients across various settings.

No contact on file

Organogenesis Inc.

Smithfield, RI

Organogenesis Inc. specializes in regenerative tissue innovations for advanced wound care, surgery, and sports medicine. The company delivers products for burn and wound care, supported by its biomanufacturing facility in Smithfield, RI, focusing on empowering healing with its range of solutions.

No contact on file

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How to Choose a Company

  • Verify their ISO 13485 certification is current and their quality system explicitly addresses FDA 21 CFR Part 820 requirements, especially for Class II and III wound care devices requiring 510(k) clearance.
  • For products with exudate management claims (e.g., hydrocolloids, alginates, foam dressings), assess their material science expertise, in-house testing for absorption capacity, and validation of moisture vapor transmission rate (MVTR) to meet your specific clinical requirements.
  • Confirm their cleanroom classification (e.g., ISO Class 7 or 8) and environmental controls are validated and regularly monitored for bioburden, ensuring the integrity of your sterile barrier system and preventing contamination of wound contact surfaces.
  • Beware of manufacturers who downplay the complexity of adhesive lamination for multi-layer dressings; inadequate experience can lead to costly delamination, poor wear time, or compromised sterile barrier system integrity in your final product.

Frequently Asked Questions

What specific regulatory certifications are non-negotiable for U.S. wound care product manufacturing?

For wound care products sold in the U.S., ISO 13485 (Medical Devices Quality Management System) is foundational. Additionally, strict adherence to FDA 21 CFR Part 820 (Quality System Regulation) is mandatory. Depending on your product's classification (Class I, II, or III), you'll also need a manufacturer experienced with 510(k) submissions, biocompatibility testing (ISO 10993 series), and sterilization validation (ISO 11135 for EO, ISO 11137 for radiation).

How do I evaluate a wound care manufacturer's cleanroom and sterilization capabilities for an `advanced wound dressing`?

Beyond confirming ISO 13485, delve into their cleanroom specifics: what ISO classification (e.g., Class 7 or 8) do they operate, and is it suitable for your sterile barrier system components? Request their environmental monitoring data, gowning procedures, and validation reports for their sterilization process (e.g., EO, gamma, e-beam). Crucially, ensure they have experience with the specific wound contact layers and adhesive lamination used in your advanced dressing, as material compatibility with sterilization can impact product performance and shelf life.

What are the key technical specifications to discuss with a manufacturer for a `hydrocolloid` or `foam dressing`?

For hydrocolloid and foam dressings, critical specifications include: desired moisture vapor transmission rate (MVTR) for effective exudate management, absorption capacity (g/100cm²), adhesive strength and skin compatibility, conformability, wear time, and biocompatibility test results (ISO 10993). Additionally, discuss film laminations, backing materials, and the required sterile barrier system to protect the dressing's integrity until use. Transparent communication on these parameters is vital for product efficacy and patient safety.

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