7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
iC-GPC Assay TM for use on the iC-SystemTM
FDA 510(k)
FDA Class 2
·Microbiology
URINE CHEMISTRY ANALYZER UR-50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 8, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·August 19, 2015