9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Intellifuse Administration and Intellifuse Blood Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO SI JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUCIA
FDA 510(k)
FDA Class 2
·Physical Medicine
GENISTRONG
FDA Adverse Event
Malfunction
·GENICON·Product code GCJ·October 15, 2017
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·Product code NPL·June 10, 2020
EDGE INSUL. COATED BLADE
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 22, 2014
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 27, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 4, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018