11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO-LOK EXTENSION SET(S)
FDA 510(k)
FDA Class 2
·General Hospital
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
FDA 510(k)
FDA Class 2
·Cardiovascular
ECO E4
FDA 510(k)
FDA Class 2
·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
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·June 2, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·January 18, 2013
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024
BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016