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Medical Receives Fda Breakthrough Device Designation Equipment & Supplies

60 equipment items found

BioStamp nPoint - Medical Device

BioStamp nPoint - Medical Device

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 ...
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Zoll Esereis - Defibrillator Medical Devices

Zoll Esereis - Defibrillator Medical Devices

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 ...
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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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Care-De - 2-Part Disposable Syringes

Care-De - 2-Part Disposable Syringes

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 ...
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Nextern - Collaborative Medical Device

Nextern - Collaborative Medical Device

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 ...
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Care-De - 3-Part Disposable Syringes

Care-De - 3-Part Disposable Syringes

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 ...
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SleepAngel - Microbiological Barrier Bedding

SleepAngel - Microbiological Barrier Bedding

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 ...
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Rythmic - Epidural Infusion Sets

Rythmic - Epidural Infusion Sets

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. ...
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MESA - Model EKG 312T - 3-Channel ECG

MESA - Model EKG 312T - 3-Channel ECG

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: ...
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MESA - Model EKG 6012 - 3/6-Channel ECG

MESA - Model EKG 6012 - 3/6-Channel ECG

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 ...
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SoftFil EasyGuide - Pre-Hole Needle & Micro-cannulas

SoftFil EasyGuide - Pre-Hole Needle & Micro-cannulas

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 ...
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SonoHealth - Model H5L - Handheld Ultrasound Scanner

SonoHealth - Model H5L - Handheld Ultrasound Scanner

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. ...
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Technimount - Standard Surface Base Mounting System

Technimount - Standard Surface Base Mounting System

Manufactured by:Technimount System   based inQuebec City, QUEBEC (CANADA)
The Standard Surface Base is a flexible and secure mounting solution for portable medical devices. The Standard Surface Base enables paramedics and emergency providers to safely install their medical devices in various applications including surfaces, floors, and stretchers/cots. SAE J3043 certified, the Standard Surface Base meets the industry’s highest standards and regulations for ...
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Medical Device Industrial Design Services

Medical Device Industrial Design Services

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 ...
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Medical Device & Equipment Design Services

Medical Device & Equipment Design Services

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 ...
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TEARPRIM - Sterile Medical Device Designed To Sample The Tear Film

TEARPRIM - Sterile Medical Device Designed To Sample The Tear Film

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 ...
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VR Life - Model VR Vitalis Pro - Molecular Hydrogen Inhalation Device for Enhanced Rehabilitation

VR Life - Model VR Vitalis Pro - Molecular Hydrogen Inhalation Device for Enhanced Rehabilitation

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 ...
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Galvanize RheOx - Investigational Device for Chronic Bronchitis Treatment

Galvanize RheOx - Investigational Device for Chronic Bronchitis Treatment

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, ...
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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 is here to help. We provide more than just Nitinol tubing, we provide vertically ...
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Camcon - Model IMOD - Oxygen Delivery Device

Camcon - Model IMOD - Oxygen Delivery Device

Manufactured by:eg Technology Ltd   based inStow-cum-Quy, UNITED KINGDOM
IMOD is the only responsive oxygen delivery device able to monitor and automatically adjust to a patient’s individual oxygen needs and requirements. The device receives oxygen from a bottled or bulk supply and reactively delivers the correct dose through a nasal cannula or a face mask, the first in its class to do so. The ultra-sensitive breath-detection system at the heart of IMODtracks ...
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