12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MIVI Mi-AXUS Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087401·
WIRED MOUTH PROTECTOR (WMP)
FDA 510(k)
FDA Class 1
·Dental
DYNAFLEX
FDA 510(k)
FDA Class 2
·Dental
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 8, 2011
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·September 4, 2008
ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
FDA Adverse Event
Malfunction
·TITAN SPINE, LLC·Product code HXX·January 28, 2016
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014