10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMMUNOCARDSTAT HPSA
FDA 510(k)
FDA Class 1
·Microbiology
AQUILION ONE VISION, V6.0
FDA 510(k)
FDA Class 2
·Radiology
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 2, 2025
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 26, 2024
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 10, 2025
AVAULTA PLUS POSTERIOR
FDA Adverse Event
Injury
·BARD PHARMACEUTICAL·Product code FTL·November 13, 2008
SROM*STM ST,36+8L NK,20X15X165
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JDI·August 18, 2011
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025