10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHARM-ASSIST
FDA 510(k)
FDA Class 2
·General Hospital
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112699·3M™ Victory Series™ Second Molar Bands, 905-116...
DESERET OPTIMA INTRAVASCULAR CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
STERILE LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 9, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 22, 2010
EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 1, 2014
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 6, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024