7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ULTRACLONE ECL-01-600 CELL LINE
FDA 510(k)
FDA Class 1
·Hematology
LIAT STREP A ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
FDA 510(k)
FDA Class 1
·Cardiovascular
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 30, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 19, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 12, 2015
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