12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
WOMEN AND INFANT'S DELIVERY PACK
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
FDA 510(k)
FDA Class 1
·Dental
PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017
PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017
BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·May 14, 2014
AIR OPTIX NIGHT & DAY AQUA
FDA Adverse Event
Injury
·CIBA VISION BATAM·Product code LPM·January 9, 2013
ACRYSOF RESTORE
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·November 10, 2010
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024
ASCENT SYSTEM-BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016
BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016