9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CO 2 SMO PLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
ECHOSTIM FACET TIP
FDA 510(k)
FDA Class 2
·Anesthesiology
Serranator Alto PTA Serration Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
JUGGERKNOT 1.4MM SHRT W/NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·March 14, 2019
M2A 38MMX54MM CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 28, 2023
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2014
2520274-2013-10286
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNI·February 13, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 20, 2010
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