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Class Ii Medical Device Equipment & Supplies

17 equipment items found

Cala Trio - FDA-cleared Class II Medical Device For Healthcare Professionals

Cala Trio - FDA-cleared Class II Medical Device For Healthcare Professionals

Manufactured by:Cala Health, Inc.   based inBurlingame, CALIFORNIA (USA)
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 each patient's unique brain signal ...
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Natrox - Oxygen Wound Therapy System

Natrox - Oxygen Wound Therapy System

Manufactured by:Inotec AMD   based inCambridge, UNITED KINGDOM
NATROX Oxygen Wound Therapy System is a class II medical device licensed under Medical Device Directive 93/42/EEC. The system consists of two main elements; the NATROX Oxygen Generator and the NATROX Oxygen Delivery System. ...
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Archimedes - Model Lite - Virtual Bronchoscopic Navigation System

Archimedes - Model Lite - Virtual Bronchoscopic Navigation System

Manufactured by:Broncus Medical, Inc.   based inSan Jose, CALIFORNIA (USA)
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 from Archimedes without fluoroscopy. Archimedes Lite is the only pulmonary navigation system that provides compatibility with any bronchoscope allowing ...
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Orlvision - Model RS1 - The New Generation Video Rhino Laryngoscope

Orlvision - Model RS1 - The New Generation Video Rhino Laryngoscope

Manufactured by:Orlvision GmbH   based inLahnau, GERMANY
The latest design in video endoscopy is the video-rhino-laryngoscope from orlvision. It was developed for endoscopy, image and video documentation especially for ENT physicians. International users confirm that the interaction of optics, illumination and camera electronics provides very meaningful ...
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Clickheart - Model CT-111 - Acute Coronary Syndrome

Clickheart - Model CT-111 - Acute Coronary Syndrome

by:Click Therapeutics, Inc   based inNew York, NEW YORK (USA)
Clickheart is under development as a clinically-validated digital program for acute coronary ...
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Click Therapeutics - Model CT-161 - Overactive Bladder

Click Therapeutics - Model CT-161 - Overactive Bladder

by:Click Therapeutics, Inc   based inNew York, NEW YORK (USA)
CT-161 is under development as a clinically-validated digital program for overactive ...
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Krylex - Industrial Cyanoacrylate Adhesives

Krylex - Industrial Cyanoacrylate Adhesives

Manufactured by:Chemence Inc   based in, GEORGIA (US) (USA)
Our company is a world leader in cyanoacrylate technology research and has developed a wide range of high-performance grades of industrial cyanoacrylate adhesives based on ethyl, methyl, methoxyethyl, isopropyl, n-butyl and octyl monomers over the years. Servicing three main industries – medical, industrial and consumer – Chemence® continues to push the ...
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Continuous Draw Nitinol Tubing

Continuous Draw Nitinol Tubing

Manufactured by:Cirtec Medical   based inBrooklyn Park, MINNESOTA (USA)
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 understand that designing devices in a highly regulated industry can be challenging and our experienced and knowledgeable Nitinol team ...
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Neuromate - Neuromate - Robotic System for Stereotactic Neurosurgery

Neuromate - Neuromate - Robotic System for Stereotactic Neurosurgery

Manufactured by:Renishaw plc   based inGloucestershire, UNITED KINGDOM
The neuromate system offers you the possibility to develop innovative and productive ways of ...
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TEEClean - Automated TEE Probe Cleaner Disinfector

TEEClean - Automated TEE Probe Cleaner Disinfector

Manufactured by:CS Medical LLC   based inCreedmoor, NORTH CAROLINA (USA)
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 and high-level disinfection of soiled TEE probes in the same device. Current methods require manual cleaning to be completed so as to achieve proper ...
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Irrisept - Irrisept Antimicrobial Wound Lavage

Irrisept - Irrisept Antimicrobial Wound Lavage

Manufactured by:Irrimax Corporation   based inLawrenceville, GEORGIA (US) (USA)
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 ...
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Integer - Portable Battery Packs

Integer - Portable Battery Packs

Manufactured by:Integer Holdings Corporation   based inPlano, TENNESSEE (USA)
Our in-depth knowledge of battery cell technologies and battery pack design, as well as medical device and regulatory expertise, drives us to be the premier portable power source to our customers. Whether you are seeking to build and power a medical device or simply seeking portable battery packs, our team of scientists and engineers will help you navigate the complexities of the numerous ...
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AVACEN - Model FDA- 510K - Heat Therapy System

AVACEN - Model FDA- 510K - Heat Therapy System

Manufactured by:AVACEN Medical   based inCarlsbad, CALIFORNIA (USA)
*FDA- 510K Clearance -Indications for Use: The AVACEN is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where ...
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AcuPebble - Model SA100 - FDA Cleared Wearable Medical Device for Home Sleep Apnea Testing

AcuPebble - Model SA100 - FDA Cleared Wearable Medical Device for Home Sleep Apnea Testing

Manufactured by:Acurable Limited   based inLondon, UNITED KINGDOM
Clinically validated: AcuPebble SA100 automated sleep apnea test was validated in a powered clinical trial at the NHS Royal Free London hospital. Validated sleep study result equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation). Validated result based on AHI and ODI for both 3% and 4% desaturation criteria with high accuracy (94% PPV, 98% ...
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NextPhase - Model EMD - Electromechanical Device

NextPhase - Model EMD - Electromechanical Device

Manufactured by:NextPhase Medical Devices LLC.   based inMansfield, MYANMAR
Looking for a turnkey, US-based, FDA-compliant EMD medical device manufacturer for your entire product life-cycle? We have a proven track record of reducing manufacturing costs by expediting development and production timelines while holding to the highest standards of quality. Our robust quality system has earned a strong reputation with some of the largest ...
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TheraLight - Model 360 - Full Body Photobiomodulation System

TheraLight - Model 360 - Full Body Photobiomodulation System

Manufactured by:Theralight, LLC   based inLindon, UTAH (USA)
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 Pulse Operating Modes, Wireless Control ...
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Autoclave - Model RS-SC-102 - FDA Cleared - (8L) Steam Saniclave

Autoclave - Model RS-SC-102 - FDA Cleared - (8L) Steam Saniclave

Manufactured by:Revolutionary Science   based inShafer, MINNESOTA (USA)
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 operation. A corrosion-resistant, stainless steel chamber makes this steam sterilizer durable and easy to clean. The Saniclave 102 delivers exceptional ...
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