9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
OMF-7101 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·May 3, 2012
CMB ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Cefaly
FDA 510(k)
FDA Class 2
·Neurology
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·June 11, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 10, 2014
KEEPSAFE DELUXE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·November 2, 2012
HUDSON HCH ASSEMBLY AQUA+ 2FH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·September 22, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012