7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
APELLO, PERSONAL HEALTH SUPPORT SYS.
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EBI XFIX OPTIROM KNEE FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 23, 2014
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
PROMOTE ACCEL CRT-D,SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015