8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OpenRad Cloud
FDA 510(k)
FDA Class 2
·Radiology
CAIMAN SEAL AND CUT TECHNOLOGY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPLETE BLINK-N-CLEAN LENS DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 10, 2014
EXCEL 36KHZ STRAIGHT HANDPIECE
FDA Adverse Event
Malfunction
·INTEGRA, ANDOVER·Product code GEI·August 16, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025