7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
FDA 510(k)
FDA Class 2
·Anesthesiology
PHARMETRIX MEDIPUMP MODEL 524
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
FDA 510(k)
FDA Class 2
·Neurology
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·February 1, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INT'L., LTD.·Product code KWA·December 30, 2010
FREESTYLE
FDA Adverse Event
Injury
·Product code LFR·July 21, 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