7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Talis EMR with Talis +ACG (Talis EMR with +ACG)
FDA 510(k)
FDA Class 2
·Cardiovascular
LAURIMED POLYPVAC MICRODEBRIDER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TELECARE D.R. SERVER SOFTWARE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008
CYLOS DR
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·July 22, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
KENSTONE METAL·Product code IOR·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025