7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LEG HOLDER
FDA 510(k)
FDA Class 2
·Orthopedic
NEPHROSTOMY/BILIARY DRAINAGE BAG
FDA 510(k)
FDA Unclassified
·Unknown
PORTABLE DIAGNOSTIC LABORATORY
FDA 510(k)
FDA Class 1
·Microbiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 10, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·October 6, 2010
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 10, 2012
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021