Founded by a radiation oncology professor and a practicing pediatrician, Bionix develops and manufactures single-patient-use medical devices that address everyday problems in patient care. For more than 40 years, its Maumee-based team of more than 100 people has combined clinical experience with product development, with particular depth in illuminated ear, nose and throat tools and other practical care solutions. Bionix products are made under ISO-certified processes and meet FDA requirements, and its OneLight platform is assembled in the USA.
ISO 13485 Certification
certification
FDA Establishment Registration & Device Listing
registration
IZI Medical ProductsFounded in 1991 by a neuroradiologist and a radiation oncologist, IZI Medical Products is a physician-founded medical device maker based in Owings Mills, Maryland. Over more than three decades, it has built a global customer base spanning 25 countries while developing solutions for clinicians performing image-guided procedures. IZI is part of Halma plc.OWINGS MILLS, MD
Nissha Medical TechnologiesWith roots stretching back more than a century, Nissha Medical Technologies designs and manufactures single-use medical technologies, including complex minimally invasive devices and clinical wearables. The Buffalo-headquartered medical devices subsidiary of Japan’s publicly held Nissha Co. operates 10 facilities across five countries, combining product design, regulatory expertise and scalable production. It also brings more than 30 years of experience to complex cable assemblies used in critical-care procedures and holds ISO 13485 certification.BUFFALO, NY
Bryan MedicalFrom Cincinnati, Bryan Medical develops and supplies airway-management devices and other ENT medical products for pediatric and adult care. Its physician-collaborative portfolio includes distinctive systems such as the Aeris airway dilation catheter and Tenax laser-resistant endotracheal tube, while its place in the SPIGGLE & THEIS Group extends its U.S. offering to German-engineered ENT instruments. Bryan Medical also represents Reliance Medical products in Ohio and Kentucky and holds nationwide GSA contracts.CINCINNATI, OH
Lumitex, LLCBorn from flexible illuminated fabric developed on a repurposed loom in 1985, Lumitex designs, develops and manufactures thin, integrated lighting systems for medical devices and other demanding applications. The Brecksville company works with medical OEMs from early concepts through prototyping, validation and production, with particular depth in surgical retractor lighting and phototherapy. Lumitex operates to U.S. FDA Good Manufacturing Practices and is certified to ISO 13485 and ISO 9001.BRECKSVILLE, OH