8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SABOURAUD DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209104826·KIT, EAGLE IFAK - BLK
MODIFICATION TO ACCU-CHEK GO SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Gemmed pedicle screw spinal system
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 29, 2012
DUROM US ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·September 27, 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