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FDA-cleared medical devices

Suppliers
3
States & provinces
3
Countries
1

3 fda-cleared medical devices suppliers across 3 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

ATHENA GTX INC

JOHNSTON, IA

Athena GTX is an Iowa-based company devoted to bringing wireless patient monitoring to the military and civilian markets. It invented and produces state-of-the-art medical and communication technology, including the Athena Device Management Suite (ADMS) software and the WVSM (Wireless Vital Signs Monitor) product line, designed for tough scenarios such as battlefield triage, mass casualty incidents, and remote medicine.

medical device software developmentmulti-patient connectivitywireless patient monitoring

CIVATECH ONCOLOGY INC

MORRISVILLE, NC

CivaTech Oncology Inc. is a North Carolina-based corporation founded in 2006 that develops and commercializes polymer-based low dose rate (LDR) brachytherapy devices for cancer treatment. Its products include CivaString®, CivaSheet® and CivaDerm™, designed to integrate into clinical workflows from imaging through treatment planning and post-implant dosimetry.

ISO 13485 productionlow dose rate brachytherapy device developmentmanufacturing in clean room environment

ERCHONIA CORP

FOUNTAIN INN, SC

Erchonia Corporation designs and manufactures FDA-cleared low-level laser therapy (LLLT) systems for pain management, fat loss and body contouring, veterinary care, and other clinical applications. The company states it earned the first FDA market clearance ever granted for low-level laser therapy and has built 25 FDA clearances since 1996 on double-blind, randomized, placebo-controlled trials.

clinical educationlaser engineeringlow-level laser therapy

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