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Class Ii Medical Device Suppliers In North America
25 companies found
based inMiamisburg, OHIO (USA)
Aerobiotix is a pioneer in air quality management solutions for healthcare, assisted living, and schools. Its medical-grade products use ultraviolet light, HEPA filters, and proprietary filtration to remove 99.9 of bacteria, viruses, VOCs, and more. ...
based inLos Angeles, CALIFORNIA (USA)
SprintRay is a technology company that builds end-to-end 3D printing ecosystems for dental professionals. Because we control the design, manufacturing, and support of our products, SprintRay is uniquely positioned to provide full-stop additive ...
High strength and resistance to wear make SprintRay Crown by BEGO® a go-to material for restorative 3D printing. And because SprintRay Crown by BEGO® is FDA 510(k) cleared and fulfills all the requirements for a Class ...
based inLawrenceville, GEORGIA (US) (USA)
Irrimax Corporation is focused on reducing infections, healthcare costs and improving patient outcomes. Innovation Technologies, Inc., parent company to Irrimax Corporation, holds the rights to US and worldwide patents that provide broad protection ...
Irrisept is jet lavage containing low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water for irrigation. CHG acts as a preservative to help inhibit microbial growth in the ...
based inCreedmoor, NORTH CAROLINA (USA)
Founded in 2003, CS Medical LLC is a leader in developing, manufacturing, and marketing medical devices that are designed to provide cleaning and high-level disinfection of ultrasound TEE probes. Our products are engineered and developed with one ...
TEEClean Automated TEE Probe Cleaner Disinfector is the first product of its kind to be cleared by the US FDA. Designed exclusively for transesophageal echocardiogram ultrasound probes (TEE), TEEClean provides both manufacturers recommended cleaning ...
based inBrooklyn Park, MINNESOTA (USA)
For over three decades, Cirtec Medical has been an industry-leading outsource partner for end-to-end product design, development and manufacturing of Class II and III medical devices, specializing in today’s most cutting-edge product technologies. ...
Long known for providing complete outsourcing solutions for Class II and III medical devices, Cirtec is pleased to announce we are now producing continuous draw Nitinol tubing. We ...
based inSan Jose, CALIFORNIA (USA)
Broncus, a pioneer in the field of Interventional Pulmonology, is a medical device company specializing in the global development and distribution of innovative lung solutions. Broncus' integrated whole lung access navigation platform addresses the ...
The Archimedes® Lite™ Virtual Bronchoscopic Navigation System, also known as LungPoint Plus® in Asia Pacific regions, is a simple, yet elegant virtual bronchoscopic navigation system that leverages the advanced navigation technology ...
based inNew York, NEW YORK (USA)
We develop, validate, and commercialize software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are ...
Clickheart is under development as a clinically-validated digital program for acute coronary ...
based inLaval, QUEBEC (CANADA)
Emovi’s technologies and AI solutions address clinical challenges that exist through the continuum of care for patients with knee pain and pathology. These challenges include patient engagement, pre-operative planning, digital and robotic surgery, ...
Optimize your athletes’ knee health. Build baselines for all athletes pre-season to help maintain knee health throughout the season. Support the athlete’s return to full performance with reduced pain and instability. Identify ...
based inNantes, FRANCE
IIMAK is a global developer and manufacturer of value-added consumable solutions for industrial and medical applications. Headquartered in Amherst, New York, IIMAK employs over 1,000 people worldwide with additional manufacturing, distribution and ...
based inBurlingame, CALIFORNIA (USA)
Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve ...
The Cala Trio device is an FDA-cleared Class II Medical Device for the external upper limb tremor stimulator* and is safe, effective, and individually calibrated to ...
based inKenmore, NEW YORK (USA)
Firefly Neuroscience specializes in Brain Network Analytics (BNA™), an FDA-cleared platform that uses AI and machine learning to analyze EEG data from rest and task states. It benchmarks results against a normative database of age-matched ...
based inKailua, HAWAII (USA)
For 12+ years, PlatinumLED Therapy Lights has been the pioneer of advanced and reliable red light therapy. The highest amount of output of any other red/NIR LED therapy light, period. Over 2x the power of any other red light on the market and now up ...
based inSan Jose, CALIFORNIA (USA)
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous ...
This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies ...
based inDallas, TEXAS (USA)
ActivePure Technologies is a leader in indoor air and surface purification, leveraging advanced Active Advanced Photocatalysis (ActivePure) Technology. Originally conceived for space travel needs, this technology brings a proactive approach to ...
based inEl Paso, TEXAS (USA)
Seisa Medical is a global full-service contract manufacturer of Class II and Class III medical devices and specialty components, ranging from implantable stents and tubing sets to pediatric and orthopedic-care products. We serve customers through ...
based inShafer, MINNESOTA (USA)
Manufacturer of Life Science Laboratory Equipment and Instrumentation ...
The FDA-approved, American Made Saniclave 102 is fashioned with a simple push-button operation. The thermally protective polymer skin eliminates burn risk. Low water and under and over-temperature alarms assure safety and effectiveness during ...
based inSaline, MICHIGAN (USA)
Medical devices change lives. We know that innovative, effective products help healthcare professionals manage the well being of their patients, allowing them to work better, faster, and more accurately. This life-changing potential comes with ...
All medical devices in the United States are regulated by the Food & Drug Administration (FDA), and understanding the FDA’s definition of a medical device as well as how the agency classifies medical devices is a crucial part of learning ...
based inRockville, MARYLAND (USA)
Founded in 2005, Maxim Biomedical (MaximBio) is a leading diagnostic healthcare company enhancing global health through the development and manufacture of trusted diagnostic solutions. Our mission is to create diagnostic products that are ...
based inGlen Head, NEW YORK (USA)
Spine Care Technologies Inc. (“SCT”) was founded in March 2018 by Roland Kiser and his former banking partner James Fitzgerald. Kiser seized on the opportunity to become fully engaged in the next generation spine care technology by applying a ...
based inLindon, UTAH (USA)
The Company was founded in 2018 with a national corporate office and warehouse in Lindon, Utah and an office and warehouse in Ft. Pierce, Florida. It has developed non-invasive photomedicine technology that is used in medical professional practices. ...
TheraLight 360 is a unique multi-wavelength LED system that combines 4 optimal therapeutic wavelengths to generate maximum results. 633nm Red Light, 810nm Near Infrared Light, 850nm Near Infrared Light, 940nm Near Infrared Light, Continuous Wave and ...
