7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BEST INDUSTRIES CARTRIDGE & GUN
FDA 510(k)
FDA Class 1
·Radiology
PROMOTOR FINAL RINSE SPERM WASH MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NOZOVENT, NASAL DILATOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·January 22, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 9, 2014
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021