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Medical Device Directive Equipment Supplied In Usa
27 equipment items found
Manufactured by:Luxfer MEL Technologies based inManchester, UNITED KINGDOM
Our development and manufacture is the ISO 13485 quality system, this is a requirement for future medical device regulations. Our dedicated facility offers high quality material and process control, this lowers customers risk. We can support programmes from kg to tonne; scalability and capability to support programmes through to success. Luxfer are technical experts in the field with experience ...
Manufactured by:MVE Biological Solutions based inBall Ground, GEORGIA (US) (USA)
Small Capacity (SC) and Extra Capacity (XC) Series Aluminum Dewars Provide Long Term Secure Storage with Low Liquid Nitrogen Consumption in a Convenient Lightweight Package. Bend Don't Break™ (Patent Pending) – a redesigned top head that deforms to absorb G-force damage to the neck area and minimize the chances of product loss through mishandling and during transportation. Semen ...
Manufactured by:Raumedic AG based inDietzenbach, GERMANY
An important corner stone is laid with the selection of the optimal plasticizer for your application. We would be glad to offer our expertise to help you make your ...
Manufactured by:Anesthesia Associates, Inc. based inSan Marcos, ALABAMA (USA)
The Peripheral Nerve Stimulator, model 00-100-PLUS, offers precision and versatility for various clinical applications. It features a lightweight, handheld design powered by a 9V battery, ensuring mobility and convenience in medical settings. Equipped with ball electrodes, the stimulator supports Twitch (1/8 sec), Train-of-Four, and both 50Hz and 100Hz Tetanus modes, selectable via intuitive ...
Manufactured by:MVE Biological Solutions based inBall Ground, GEORGIA (US) (USA)
The freezers are designed for pull and pack shipment, with a wide neck opening for easy access. Although engineered for full liquid storage, the MVE Stock Series can be operated with vapor using associated vapor storage accessory ...
Distributed by:Susquehanna Micro Inc. based inHallam, PENNSYLVANIA (USA)
The MiniOx I Oxygen Analyzer is an incredibly portable unit designed for spot-checking or continuous monitoring of oxygen concentrations without alarms. The analyzer quickly and accurately measures oxygen concentrations, whether in life support, respiratory care, or government equipment. The MiniOx I is suitable for hospital, homecare or government/military ...
Manufactured by:Tekni-Plex based inWayne, PENNSYLVANIA (USA)
CELLENE is a range of thermoplastic elastomer compounds that combine the performance benefit of vulcanized rubber with the processing properties of thermoplastics. CELLENE TPE compounds are suitable for a wide variety of applications in medical devices, packaging and other regulated markets. CELLENE compounds are formulated to be silicone, latex, phthalate and halogen free using FDA-compliant raw ...
Manufactured by:Terumo Aortic based inRenfrewshire, UNITED KINGDOM
TREO provides a wide range of endovascular device configurations to address the abdominal anatomy of each individual ...
Distributed by:Susquehanna Micro Inc. based inHallam, PENNSYLVANIA (USA)
The MSA MiniOx 3000 Oxygen Monitor is designed for portable, continuous oxygen analysis and monitoring. This handheld, easy-to-use monitor is ideal for "in line" oxygen monitoring, with applications for hospital and home ventilators, NICU, anesthesia delivery equipment and industrial or military equipment. Hospitals, homecare, and government/military institutions have all found applications for ...
Manufactured by:Vitalograph Inc based inLenexa, KANSAS (USA)
The Vitalograph 6MWT solution includes a tablet running the 6MWT protocol, SPO2 monitor and kit to mark the ...
by:Sterling Medical Devices based inMoonachie, NEW YORK (USA)
All medical devices sold in the EU must have a Clinical Evaluation Report (CER) as part of its technical documentation to satisfy the new EU Medical Device Regulation (MDR) requirements. A comprehensive analysis of pre- and post-market data relevant to a medical device, a Clinical Evaluation Report demonstrates that your device achieves its intended purpose without exposing users and patients to ...
Manufactured by:Terumo Aortic based inRenfrewshire, UNITED KINGDOM
RELAY® endovascular devices are designed to help you achieve maximum precision and control in the thoracic ...
Manufactured by:Gebauer Company based inCleveland, OHIO (USA)
Gebauer's Spray and Stretch is an instant topical anesthetic skin refrigerant that effectively manages myofascial pain and trigger point release when used in conjunction with the spray and stretch technique. Our spray is also indicated for treating muscle spasms, restricted motion, and minor sports ...
Manufactured by:Vitality Medical based inSalt Lake City, UTAH (USA)
Precision Medical PM4150 EasyPulse Portable Oxygen Concentrator reduces costly cylinder deliveries while providing increased mobility for your patient. EasyPulse POC combines the functionality of the popular EasyFlow 5 Conserver with a highly efficient portable oxygen concentrator to bring your patient the best and most cost-effective oxygen therapy. Its innovative CMV technology delivers a ...
Manufactured by:Forécreu based inChicago, ILLINOIS (USA)
Forécreu is a leader in manufacturing stainless steel tubing solutions for medical instrumentation, emphasizing the critical role of high-quality stainless steels, particularly in single-use applications. The company utilizes PH austenitic and martensitic stainless steels, recognized for their corrosion resistance, durability, and reliable mechanical properties in challenging environments. ...
Manufactured by:Advanced Sterilization Products (ASP) based inIrvine, CALIFORNIA (USA)
Enhances safety to meet your sterilization needs. STERRAD NX® System with ALLClear® Technology is the compact unit from the STERRAD® Systems platform. It includes two sterilization cycles that can reprocess over 23,000 medical devices and can be placed on a cart or countertop when constrained for ...
Manufactured by:Spire Integrated Solutions based inOrlando, FLORIDA (USA)
These sterilizers are designed for all Healthcare applications including surgery, central sterile supply and clinical laboratories. PRIMUS sterilizers are designed and manufactured in the USA according to Quality Management Systems which are in compliance with ISO 9001:2008, ISO 13485:2003, CMDCAS and FDA's Good Manufacturing Practice (GMP) for Medical Devices: General regulation (21CFR Part ...
Manufactured by:VIDAR Systems Corporation based inHerndon, VIRGINIA (USA)
Medical film digitizing is an imaging procedure governed by medical and industry regulations. The Dental Film Digitizer from VIDAR is specifically tailored for the dental application and is a regulated medical device for use in diagnostic applications. Special attention must be paid to the unique challenges of accurately and reliably visualizing the details in medical films since decisions will ...
Manufactured by:Advanced Sterilization Products (ASP) based inIrvine, CALIFORNIA (USA)
Enhances safety to meet your sterilization needs. STERRAD® 100NX System with ALLClear® Technology is one of the latest releases from the STERRAD® Systems platform, featuring over 25 years of innovation in hydrogen peroxide gas plasma (HPGP) sterilization technology. It includes up to four sterilization cycles – STANDARD, EXPRESS, FLEX, and DUO – to sterilize a variety of ...
Manufactured by:Focus Laboratories Inc. based inBethlehem, PENNSYLVANIA (USA)
Once the bioburden of the medical device is understood, appropriate parameters can be established for assuring device sterility. Sterility must be verified, and this is typically accomplished by direct immersion of the devices in media and incubation for times prescribed by USP ...