7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ADVANTAGE WINDOWS (AW) FUSION
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
FDA 510(k)
FDA Class 2
·Anesthesiology
GlideScope BFlex Single-Use Bronchoscope System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 1, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015