8 results
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19ms
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Sources: EU EUDAMED, US FDA
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
Zuma
FDA UDI
Seaspine Orthopedics Corporation·10889981097394·Mask Handle
ACTH IRMA KIT II MITSUBISHI YUKA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·February 11, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 18, 2014
TENDRIL ST
FDA Adverse Event
Injury
·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