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Sources: EU EUDAMED, US FDA
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Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
FDA Enforcement
Class II
·Terminated·Numed Inc·December 5, 2018
Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
FDA Enforcement
Class I
·Terminated·Merit Medical Systems, Inc.·April 5, 2017
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
Food Intolerance Test Small
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Lactose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Mycotoxin Panel Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Fructose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Intestinal Worms Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Iodine Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Menopause (FSH) 2 Tests
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Biological Age & Longevity Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Iron Deficiency Test (ferritin)
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Men s Hormone Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
IBS Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Gut Microbiome Test Medium
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Candida Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025