7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TABLE, EXAMINATION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sterisheet Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
PRO-DENSE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
ROTALINK? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·April 24, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 3, 2012
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