8 results
·
36ms
·
Sources: EU EUDAMED, US FDA
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
FDA 510(k)
FDA Class 2
·Radiology
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 26, 2015