8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NSULIN RIA KIT 125I
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HBS2 Headless Bone Screw
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 24, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 24, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 4, 2012
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·July 27, 2010
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016