8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
FDA 510(k)
FDA Class 2
·Immunology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209112173·KIT, INDIVIDUAL BLEEDING CONTROL - RED - CUSTOM
Lantern Delivery Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
IGI-SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 6, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 5, 2010
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA INC.·Product code MEA·November 27, 2012
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018