8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FILTER, PARTICULATE ARRESTING
FDA 510(k)
FDA Class 2
·General Hospital
LIBERTY GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Vivo 60
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 26, 2012
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 19, 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
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025