9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
BEST STRAP RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
FDA 510(k)
FDA Class 2
·Radiology
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
FDA 510(k)
FDA Class 2
·Cardiovascular
2520274-2013-10288
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNI·February 13, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·January 14, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·July 29, 2014
NEONATAL MONITORING KIT
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·August 10, 2015
NEONATAL MONITORING KIT
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DRS·August 10, 2015
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015