3 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
FDA Enforcement
Class II
·Ongoing·Edan Diagnostics·January 28, 2026
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025