7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ACCULATOR 487E
FDA 510(k)
FDA Class 2
·Neurology
derma+flex QS High Viscosity Tissue Adhesive
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRS SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·XOMED MFG JACKSONVILLE·Product code ERL·December 10, 2012
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·June 23, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020