7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
KODAK X-OMATIC RADIATION THERAPY CASS
FDA 510(k)
FDA Class 2
·Radiology
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UltraLinq
FDA 510(k)
FDA Class 2
·Radiology
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 2, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 23, 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