4 results
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43ms
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Sources: EU EUDAMED, US FDA
GRASEBY MS26 AMBULATORY SYRINGE DRIVER
FDA Adverse Event
MARCAL MEDICAL, INC.·Product code FRN·October 22, 1996
TRIFURCATED SUBCUTANEOUS TISSUE INFUSION SET
FDA Adverse Event
Injury
·MARCAL MEDICAL INC.·Product code FOZ·December 9, 2005
GRASEBY MEDICAL
FDA Adverse Event
Malfunction
·MARCAL MEDICAL INC·Product code FRN·February 20, 2001
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views
FDA Recall
Terminated
·Infraredx, Inc.·Product code OGZ·December 15, 2016