9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ANUS STIMULATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517205803·CoRoent® SI, 11x19x16mm 10° Ta
RADCALC SOFTWARE, VERSION 6.0
FDA 510(k)
FDA Class 2
·Radiology
UNICAM I
FDA 510(k)
FDA Class 1
·Radiology
CAPTIFLEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 5, 2014
ADVISA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·October 15, 2012
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 10, 2010
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025