8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LATEX EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
SURESHOT Distal Targeting System V4.0 Trauma Interface
FDA 510(k)
FDA Class 2
·Neurology
CARDIOVASCULAR SPRING GUIDES
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCOS 19X190MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 30, 2019
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·February 15, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 6, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 31, 2014
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·April 3, 2013