7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
FDA 510(k)
FDA Class 1
·General Hospital
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
FDA 510(k)
FDA Class 2
·Radiology
PoreStar Patient Specific Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD / HUNTINGTON·Product code HQL·December 18, 2013
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014