7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MUFFLER, AIR PUMP
FDA 510(k)
FDA Class 2
·Anesthesiology
S.I.N. Implant System
FDA 510(k)
FDA Class 2
·Dental
MOSAIC LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 13, 2010
VASOVIEW HEMOPRO 2 WITH VASOSHIELD
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 24, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·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