7 results
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25ms
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Sources: EU EUDAMED, US FDA
BUHLMANN VITAMIN B6 REA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
FDA 510(k)
FDA Class 1
·Dental
ZEISS MULTIYAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SL-PLUS MIA
FDA Adverse Event
Injury
·AARAU SWITZERLAND MANUFACTURING SITE·Product code JDH·February 11, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·July 24, 2014
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
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