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Medical Receives Fda Breakthrough Device Designation Equipment & Supplies
72 equipment items found
by:MC10 based inLexington, MASSACHUSETTS (USA)
BioStamp nPoint is an FDA 510(k) cleared medical device designed to collect medical grade, clinical quality bio-metric, physiological and eCOA data in a clinical trial ...
Manufactured by:SakoMed, LLC based inLaguna Niguel, CALIFORNIA (USA)
The ZOLL E Series defibrillator medical devices were designed by professionals for professionals. No other full-featured defibrillator was designed specifically for the rigors of your EMS environment. No other defibrillator offers the configurable options of the E Series. Documentation is made easy when combined with data transfer options that take the “paper” away. No other ...
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 ...
Manufactured by:Changzhou Care-de Sanitary Material Co., Ltd. based inChangzhou, CHINA
User Convenience: Ergonomic design, smooth flow, highly transparent barrel, tight, black extended graduation, and easy to read. User Safety: Individually blister packed and the needle is side-packed in a single blister package. Comfort: Designed tip for best connection, scratch-free for glove manipulation, and centrically positioned Luer lock tip. Patient Safety: Single-use only. Low dead space ...
Manufactured by:Nextern Inc based inWhite Bear Lake, MINNESOTA (USA)
Nextern is a collaborative medical device company. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of their ...
Manufactured by:Changzhou Care-de Sanitary Material Co., Ltd. based inChangzhou, CHINA
User Convenience: Ergonomic design, smooth flow, highly transparent barrel, tight, black extended graduation and easy to read. User Safety: Individually blister packed and the needle is side-packed in a single blister package. Comfort: Designed tip for best connection, scratch-free for glove manipulation and centrically positioned Luer lock tip. Patient Safety: Single-use only. Low dead space ...
Manufactured by:Micrel Medical Devices SA based inAthens, GREECE
Our innovative Rythmic™ Yellow Infusion Sets contain all necessary components such as air eliminator filter, non-return and anti-siphon valve and extension line. The design of the sets improves efficiency, while reducing hazards and false alarms. Air removal during filling and priming is easy and safe. These sets are colour coded in yellow colour to prevent medication delivery error. ...
Manufactured by:Elers Medical Finland Ltd. based inEspoo, FINLAND
CE-marked award winning SleepAngel® bedding products by Gabriel Scientific are clinically proven barriers against pathogens. SleepAngel®, Class I Medical Devices, designed without seams or zippers are a proven part of HAI reduction in clinical environments. Ventilation is enabled through the PneumaPure™ microbiological filter on the cover. PneumaPure™ Filter Technology enables ...
Manufactured by:MESA Medizintechnik GmbH based inBenediktbeuern, GERMANY
The EKG312T is a 3-Channel ECG with built in rechargeable battery and touch screen. It is an easy-to-use medical device especially designed for recording, measurement and interpretation of resting ECGs. The EKG312T will be delivered completely with 10 lead patient cable with 4mm banana connector, 6 pcs. chest suction electrodes, 4 pcs. limb electrodes and ground cable. Optional accessories: ...
Manufactured by:MESA Medizintechnik GmbH based inBenediktbeuern, GERMANY
The EKG 6012 is a 3/6-Channel ECG with built in rechargeable battery and 7” Touch screen. It is an easy-to-use medical device especially designed for recording, measurement and interpretation of resting ECGs. The EKG 6012 will be delivered completely with 10 lead patient cable with 4mm banana connector, 6 pcs. chest suction electrodes, 4 pcs. limb electrodes and ground cable. Optional ...
Manufactured by:SoftFil | Soft Medical Aesthetics based inParis, FRANCE
THE SMART NEEDLE FOR OPTIMIZED CANNULA INJECTIONS. SoftFil® EasyGuide is a MEDICAL DEVICE UNDER INTERNATIONAL PATENT. Designed by doctors, approved by opinion leaders, SoftFil® EasyGuide is the essential tool that optimizes injections. A true partner to the micro-cannula, its pre-hole needle guides the cannula and facilitates the physician’s gesture. The injection 2.0 becomes fluid ...
Manufactured by:Guangzhou SonoHealth Medical Technologies Co.,Ltd. based inGuangzhou, CHINA
The SonoHealth Handheld Ultrasound Scanner is an advanced medical device designed to provide high-quality imaging for superficial applications. This scanner condenses the main unit into a compact and lightweight circuit board, which is integrated into the probe. The device communicates with smartphones and tablets through an internal WiFi network or USB connection to display the captured images. ...
Manufactured by:Case Medical, Inc. based inSouth Hackensack, NEW YORK (USA)
The SteriTite Universal Sterilization Container System from Case Medical is a robust solution for reusable medical packaging, designed specifically to enhance efficiency and sustainability in healthcare sterilization processes. As a universal system, these containers are compatible with all sterilization modalities, including pre-vacuum steam and low-temperature systems, making them adaptable for ...
Manufactured by:OPIA Technologies based inPARIS, FRANCE
TEARPRIM is a sterile medical device designed to sample the tear film. It enables further analysis of tear components to help diagnose several ocular surface disorders, such as dry eye or allergies. The TEARPRIM device was developed in close collaboration with Quinze-Vingts Hospital and ...
by:Sterling Medical Devices based inMoonachie, NEW YORK (USA)
In the general perspective, product design necessitates that your product can fundamentally work for its purpose, be aesthetically well received by its users, and be economically manufactured with cost-effective materials. However, the high-quality demands of industry markets can become a challenge when approached independently. Sterling’s medical device industrial design consultations ...
by:Sterling Medical Devices based inMoonachie, NEW YORK (USA)
Medical product design is a crucial phase in the product development lifecycle. A mix of art and science, the design of life-improving medical devices that align with healthcare regulatory requirements and meet end-user needs is a complex process that requires innovation, precision, and advanced ...
Manufactured by:Safeguard Medical based inHuntersville, NORTH CAROLINA (USA)
The Russell Chest Seal is an advanced medical device designed for managing open chest wounds and bleeding. It incorporates a hydrogel-based multi-layer dressing featuring a low-profile, four-aperture valve for optimal performance. Mounted on a non-woven fabric, this seal provides a flexible and consistently adhering surface, supported by a silicone-coated release liner to prevent stretching or ...
Manufactured by:Galvanize Therapeutics, Inc. based inRedwood City, CALIFORNIA (USA)
The RheOx System is an innovative medical device designed to alleviate symptoms associated with chronic bronchitis. It combines a specialized electrosurgical generator and a single-use catheter to deliver Pulsed Electric Field (PEF) energy non-invasively. This system targets and ablates abnormal mucus-producing cells within the airways, while preserving the integrity of the extracellular matrix, ...
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 is here to help. We provide more than just Nitinol tubing, we provide vertically ...
by:VR LIFE s.r.o. based inOstrava, CZECH REPUBLIC
A medical device designed to meet the needs of patients in healthcare facilities. The immersive effect of our application leads to the suppression of pain and unblocking of the patient's fears. This leads to faster improvement in their condition. Patients are more motivated to exercise. A unique connection with the inhalation of molecular ...