8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
VASORING* VRC VASCULAR RING CONNECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HALLU PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
CONCORD 72
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·April 16, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 18, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 17, 2008
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015