Founded in Pennsylvania in 2009, ORICARE Inc. is a U.S.-based medical-device manufacturer focused on equipment for operating rooms and intensive care units. Its products are used in hospitals internationally, with installations reported in places including Stanford Hospital and Australian hospitals. ORICARE holds ISO 13485 certification and has received FDA 510(k) clearance for an ICU ventilator.
ISO13485
certification
CE approval
certification
FDA 510(k) clearance for Anesthesia Machine
registration
FDA 510(k) clearance for ICU Ventilator
registration
CircadianceFounded in 2006 near Pittsburgh by medical-device engineer David Groll, Circadiance develops and manufactures respiratory-care equipment and remote patient-monitoring systems. The company is best known for SleepWeaver, the first all-cloth positive-airway-pressure mask, and also supports infant and pediatric care through SmartMonitor and Synergy Cloud products. Circadiance is ISO 13485 certified and distributes its products internationally.EXPORT, PA
Instrumentation Industries, IncSince 1967, Instrumentation Industries, Inc. has manufactured respiratory-care and other medical components in Pittsburgh, including the adapters, connectors and emergency ventilation parts used in clinical settings. The company molds plastic and silicone and fabricates metal in-house, supporting OEM customers from prototypes through production with its own tooling, machining, engineering and assembly capabilities. Its products are made in the USA, and the facility is ISO 13485:2016 certified.BETHEL PARK, PA
ICU MedicalBased in San Clemente, California, ICU Medical is a global medical-device manufacturer known for building tools around the demanding realities of clinical care. Its worldwide operations include a 650,000-square-foot vertically integrated plant in Costa Rica and the company’s largest manufacturing site in Tijuana, where approximately 2,500 people work. ICU Medical supplies healthcare providers with technology and services centered on safer, more efficient patient care.SAN CLEMENTE, CA
FareTec IncFounded in 1991, FareTec Inc. manufactures medical devices for pre-hospital care, tactical operations and wilderness medicine from its Painesville, Ohio facility. The company is best known for its traction splints and patient-transport equipment, including products adopted by the U.S. military and NATO countries, while also producing tactical first-aid kits and portable temperature-controlled containers. FareTec’s devices are made in the USA and its quality system is certified to ISO 13485, with FDA and CE/MDR documentation.PAINESVILLE, OH