Since its founding in 1997, Kernel Medical has grown into a 1,000-employee medical-device manufacturer with a 5,000-square-meter factory in Xuzhou. Known for its long-standing work in dermatology phototherapy, the company supplies regulated equipment to customers in more than 100 countries and is a designated United Nations supplier. Its products are certified to CE, FDA and ISO 13485 requirements.
CE
certification
FDA
certification
ISO
certification
ISO13485
certification
National High-Tech Enterprise
registration
Intellectual Property Advantage Enterprise
registration
United Nations supplier
registration
Psoria-Shield IncSince 2009, Utica-based Psoria-Shield Inc. has researched and developed medical phototherapy equipment, centered on its Enhanced Aurora™ system for targeted treatment of vitiligo, psoriasis, eczema and other dermatological conditions. The compact system combines UVA and narrowband UVB diode technology in one device, is FDA-cleared as a Class II medical device, and is designed for precise, uniform treatments without toxic gases or scheduled maintenance.UTICA, NY
Xodus Medical IncFounded by Craig and Mark Kaforey, Xodus Medical manufactures medical-device solutions that make surgery safer, with a particular focus on patient positioning and operating-room safety. The New Kensington company introduced its first patient-safety product in 1994 and has since developed more than 1,100 solutions used at over 10,000 sites in more than 55 countries. Xodus also provides private-label manufacturing for major medical suppliers and holds ISO 13485:2016 certification.NEW KENSINGTON, PA
Exsurco MedicalFrom its stand-alone medical-device manufacturing facility, Exsurco Medical engineers and makes precision devices for skin grafting, wound debridement, and tissue-bank recovery. The Wakeman company’s Amalgatome platform grew from tissue-bank tools into the Amalgatome SD, a surgical device for burn and trauma care, while its products have expanded into international tissue-bank markets. Exsurco opened its manufacturing facility and received ISO 13485 certification in 2015.WAKEMAN, 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