7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PureFlex Arterial Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·April 7, 2014
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·October 25, 2010
ACRYSOF
FDA Adverse Event
Injury
·ALCON LABORATORIES IRELAND LTD.·Product code HQL·December 14, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020