7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
SMART 2940 D ER: YAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TrueBeam, TrueBeam STx, Edge, VitalBeam
FDA 510(k)
FDA Class 2
·Radiology
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 16, 2010
DRILL/SCREW GUIDE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·January 28, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024