7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ALSA-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
HAND-CARRIED STRETCHERS
FDA 510(k)
FDA Class 1
·General Hospital
MEDIPART FACE MASK MP-XM
FDA 510(k)
FDA Class 1
·Anesthesiology
DIMENSION VISTA 1500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·February 5, 2013
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM USA·Product code DZE·December 23, 2010
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. TAIWAN·Product code INI·July 18, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021