8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
3MHZ ANNULAR ARRAY
FDA 510(k)
FDA Class 2
·Cardiovascular
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
FDA 510(k)
FDA Class 2
·Cardiovascular
OTICON I31 CITE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HXX·June 11, 2014
DA+ C SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·October 12, 2010
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·December 10, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020