7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
CATHETERIZATION FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NexGen Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
GEL FILLED GUM SOOTHER
FDA 510(k)
FDA Class 2
·Dental
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 16, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025