7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SODIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOCT COPERNICUS, MODEL 15205
FDA 510(k)
FDA Class 2
·Ophthalmic
AQUAMATIC K-77
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 28, 2007
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 4, 2012
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018