12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACACIAS PHARM/PUMP
FDA 510(k)
FDA Class 2
·General Hospital
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA 510(k)
FDA Class 2
·Cardiovascular
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BILATERAL DOUBLE BALLOON SET
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006
TERUMO STERNAL SAW II
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·May 14, 2014
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·December 2, 2010
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·July 25, 2018
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023