7 results
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17ms
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Sources: EU EUDAMED, US FDA
MICRO21 WITH RETIC
FDA 510(k)
FDA Class 2
·Hematology
SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPEDANCE TESTER (MODEL 4390)
FDA 510(k)7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 30, 2013
ENTRUST AT
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·January 14, 2011
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 28, 2014
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016