8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSTEOTOMES FOR CUTTING BONH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AVIAFIT PULSATING LEGBAND
FDA 510(k)
FDA Class 2
·Cardiovascular
QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 10, 2017
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 6, 2013
ALLURA XPER FD20
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IZI·December 30, 2010
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 31, 2014
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021