12 results · 20ms · Sources: EU EUDAMED, US FDA

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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