7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
FDA 510(k)
FDA Class 2
·Cardiovascular
EPIC Extremity Fracture Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ION?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 13, 2014
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 13, 2012
REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020