7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
FDA 510(k)
FDA Class 3
·Cardiovascular
AMSINO SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECICE Intramedullary Limb Lengthening System
FDA 510(k)
FDA Class 2
·Orthopedic
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·June 5, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·October 1, 2010
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·November 20, 2012
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