10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
URINARY LEG BAG, STEOILE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LANEX Regular Screens
FDA UDI
CARESTREAM HEALTH, INC.·60889971771438·PR 35X43CM LANEX SCR REG C2
VirtuOst Vertebral Fracture Assessment
FDA 510(k)
FDA Class 2
·Radiology
NUVASIVE OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 24, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 4, 2012
PROSTHESIS, INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 14, 2015
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
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