7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DANEKSCOPE OPTI-PROBE
FDA 510(k)
FDA Class 2
·Orthopedic
Duet External Drainage and Monitoring System (EDMS)
FDA 510(k)
FDA Class 2
·Neurology
B40i Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 15, 2010
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·February 5, 2013
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020