medical device manufacturing

Cinova Medical is an engineering-driven contract manufacturing organization (CMO) serving the medical device and life science industries. Using manual, semi-automated and fully automated manufacturing work cells, it produces high precision injection molded and machined components and class II, sterile barrier finished medical devices. It is FDA Registered and ISO-13485:2016 certified and serves markets including cardiac & interventional, drug delivery, diagnostics, electro-mechanical, infusion, ophthalmology, orthopedics and surgical.

3D printinginjection moldingMetals & Plastics Machiningmold manufacturingsecondary operations

Clarus Medical manufactures and maintains medical devices that assist in saving lives, minimizing patient trauma and reducing medical costs. The company has over 30 years experience designing and manufacturing small diameter, high-quality medical endoscopes and partners with leading medical companies as their OEM manufacturer. Products are manufactured in an ISO 13485 certified cleanroom facility.

endoscope design and manufacturingISO 13485 certified cleanroom manufacturingOEM manufacturingprivate label manufacturing

CONMED is a global medical device manufacturer that designs, builds, and distributes clinical products and surgical technologies for orthopedic and general surgical specialties, as well as patient monitoring needs, to medical institutions around the world. Its offerings include insufflation, electrosurgery, smoke evacuation, surgical imaging, and surgical power tools.

design and distribution of surgical technologies

Coram Technologies is a startup founded and led by Dr. Henry Halperin to commercialize new medical devices, including CPR related technologies and new, interactive educational approaches such as video game based learning. The company focuses on medical device development and manufacturing.

medical device development

DeRoyal is a USA-based global medical device manufacturer founded in 1973, committed to improving both the clinical quality and economic health of its customers. It delivers high quality medical products and innovative healthcare solutions to healthcare providers and their patients.

OEM partnershiptextiles

Dilon Technologies Inc. is a medical device manufacturer based in Newport News, Virginia, that develops, manufactures, and promotes innovative medical devices for healthcare providers. It describes itself as a women's healthcare company that has expanded into biosurgery, with a mission to unite technology and talent to eradicate breast cancer. Its portfolio includes the Navigator System surgical gamma probe, MarginProbe for margin assessment in breast cancer surgery, and the CoPilot video laryngoscope.

medical device development

Enexor Health Systems designs, develops, and manufactures American-built medical equipment, including critical care respiratory devices. The company began as an emergency response, engineering emergency ventilators during the COVID-19 ventilator shortage, and received FDA Emergency Use Authorization for the VENT-LS critical care ventilator, which was placed in 27 U.S. hospitals. It is now designing the next generation of critical care respiratory devices.

medical device designmedical device development

EnviroPouch® is the first reusable steam sterilization pouch, a product brand of medical device manufacturer EnviroPak, LLC, based in Peachtree City, Georgia. Co-founded by dentists/brothers Drs. David and James Stoddard, the FDA-registered, class II medical device pouches can be reused a minimum of 200 times, reducing waste, storage space, and sterilization costs compared to disposable autoclave bags.

steam sterilization pouch production

Epimed is a medical device manufacturing company with locations in Dallas, TX and Johnstown, New York. For more than 40 years it has produced needles and catheters for Interventional Pain Medicine and Regional Anesthesia procedures. It is a development, design, manufacturing and distribution company providing medical training, patient education, physician support, and OEM manufacturing.

distributionmedical device designmedical trainingOEM manufacturingphysician education

Falck Medical, Inc. is a U.S. FDA registered medical device manufacturer whose primary product, the Falck Multifunction Device (FMD), is the only device cleared by the U.S. FDA for Ophthalmodynamometry, Tonography, Serial Tonometry, and Dry Eye Testing. The company was co-founded over a decade ago by CEO Francis Y. Falck Jr., MD, PhD, MS, a practicing ophthalmologist. The FMD is certified by TUV Rheinland for worldwide distribution and the technology has over 10 national and international patents.

design and testingFDA clinical trialsoptical measurementprototyping

FAST TRACK MEDICAL SOLUTIONS LLC is a manufacturer of thoracic seals (chest seals) and specialty medical bandages. Its products include the FASTBreathe Thoracic Seal (FTS), which uses patented valve technology and proprietary hydrogel Hydroseal Technology adhesive that bonds to bloody, wet, or dry skin, and the FAST Combat Wound Seal (CWS)6, a no-valve adhesive bandage used to cover and occlude exit wounds. The products were developed by medics and doctors and are laboratory and field-tested.

Hydroseal Technology hydrogel adhesivepatented valve technology

FootScientific develops orthotic insoles, drop foot braces, and compression socks designed with clinical input from board-certified orthopedic surgeon Dr. Rob Faux. Its Arches orthotics line offers three corrective designs for flat, neutral, and high-arch feet, and its Elevate 360° and Elevate Child braces address drop foot. Products are FDA registered and ISO certified for medical use.

orthotic designresearch and development

Fourth State Therapeutics LLC is a medical device manufacturer and Cold Atmospheric Plasma systems consulting firm located in State College, PA. It leverages technology and expert insights to develop novel Cold Atmospheric Plasma devices.

Cold Atmospheric Plasma systems consultingdevelopment of Cold Atmospheric Plasma devices

Gulden Ophthalmics is a US manufacturer and supplier of ophthalmic instruments and medical devices, based in Elkins Park, Philadelphia, PA. Since 1938 it has manufactured ophthalmic medical devices and offers custom plastic manufacturing services. The company is certified to manufacture medical devices according to ISO 13485:2016.

assemblycuttinglaser cutting and engravingmillingpad printingplastic polishing to optical clarityprototypingsanding

HD medical (Healthy Design) is a Rutland, Vermont-based medical device manufacturer founded by Marie Pavini, MD. The company ideates, prototypes, engineers and manufactures its products onsite, and partners with academic facilities and the NIH. It develops patient mobility, restraint, delirium and education solutions for care teams, and was named SBA Small Business Manufacturer of the Year for New England and Vermont 2024.

Auditingconsultingengineeringprototypingvirtual reality education

Hemanext is a biomedical technology company based near Boston, MA, with a corporate office in Lexington and a manufacturing site in Avon, MA. It developed Hemanext ONE, an oxygen-controlled processing and storage system that removes oxygen from red blood cell units during processing and maintains a low oxygen environment throughout refrigerated storage to preserve red cell quality.

oxygen-controlled blood storagered blood cell processing

Hood Laboratories, founded in 1962, is a manufacturer of medical devices focused on managing specific medical conditions associated with the head, neck and chest. It was the original manufacturer of T-Tubes for the otolaryngologist and has introduced products for health care professionals in rhinology, allergy, laryngology, speech therapy, thoracic surgery, and interventional pulmonology. Effective May 1, Everis acquired Hood Laboratories.

custom/patient specific prosthesisresearch and development

IMT is a medical device manufacturer founded in 1998 and headquartered in Georgia, USA, committed to treating blindness through ophthalmic products. It designs and manufactures intraocular lenses and corneal rings for doctors and their patients, with manufacturing processes based on ISO 13485 requirements and production in a single dedicated facility. IMT offers surgical planning for implant techniques and serves clients worldwide.

ISO 13485 manufacturing processeslens polishingprogressive apodization techniquesurgical planning

Infinium Medical, Inc. is a USA manufacturer of patient monitoring systems and critical care equipment, headquartered in Largo, Florida. Its monitors are manufactured at an FDA registered, ISO 13485 certified facility, and the Omni and Cleo lines carry EU MDR and CE certification. The company supplies medical equipment for outpatient centers, hospitals, and clinics, with 500+ equipment SKUs and distribution to 87 countries.

after-sales and warranty servicecentral station network monitoringFDA registered facilityHL7 compliant connectivityISO 13485 certified manufacturingparts and repairs

Jigsaw Medical® is an SBA-certified woman owned and operated medical device manufacturer and distributor based in the greater Chicago, IL area. Formed in 2013, it serves healthcare providers, hospitals, healthcare systems, and home health agencies nationwide with specialized products for diagnostic and interventional radiology, ultrasound, home health, wound care, and surgery.

medical device distribution

Dedicated to the Needs of Cardiac Surgeons Dedicated to the Needs of Cardiac Surgeons Beating Heart Surgery A complete portfolio of disposable devices for off-pump, on-pump and pump-assist Coronary Artery Bypass Graft (CABG) procedures. Surgical Arms and Attachments Next generation design in reusable positioning technology with reusable and disposable attachments OVER 25 YEARS OF EXPERIENCE Women-Owned, Small Business. Chase Medical is an ISO 13485 certified medical device manufacturer and worldwide distributor, focused on state-of-the-art technologies for advanced cardiovascular disease. Physicians More about Beating Heart, and Surgical Ventricular Restoration systems. New Topic New description Link here New Topic New description Link here New Topic New description Link here

ISO 13485 certifiedproduct developmentworldwide distribution

Kwell Laboratories Inc. is the U.S. affiliate of GenBody (Korea), founded in 2020 to deliver reliable, accessible, and innovative diagnostic solutions. It is an FDA-registered and ISO 13485-certified medical device manufacturer and packager holding a California Medical Device Manufacturing License, operating under strict GMP standards. It imports FDA-cleared IVD products and manufactures select assays domestically to serve clinical labs and healthcare providers nationwide.

assay manufacturingimporting FDA-cleared IVD productslarge-scale distributionpackaging