8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
FDA 510(k)
FDA Class 1
·Cardiovascular
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
FDA 510(k)
FDA Class 2
·Neurology
Ysio Max
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 27, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2010
VERSASTEP PLUS LONG 12MM CANN + DILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·November 14, 2012
12MM / TI CANN FRN / GT 440MM / RIGHT - STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·December 5, 2022
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020