11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BDS-3 BEAM DATA SCANNER
FDA 510(k)
FDA Class 1
·Radiology
FRONT RADIUS CUTTER
FDA 510(k)
FDA Class 1
·Orthopedic
TPN/CVP DRESSING CHANGE KIT
FDA 510(k)
FDA Class 1
·General Hospital
BIVONA TTS TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016
BIVONA TTS TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016
BIVONA TTS TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016
BIVONA TTS TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·June 3, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 12, 2012
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, MEDOS S.A.·Product code JXG·September 23, 2010
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020