68 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMGUARD ONE-STEP STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
FDA 510(k)
FDA Class 2
·Hematology
VENTVIEW, MODEL 8414095
FDA 510(k)
FDA Class 2
·Anesthesiology
CUSTOM TUBING - SET INC. OXYGENATOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 24, 2015
IPC® STYLUS TRANSNASAL BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·February 6, 2015
QUADROX COMPLETE PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 24, 2014
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·September 16, 2011
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code ERL·June 19, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWF·July 13, 2015
QUADROX-I HMO 70000+VHK70000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 7, 2015
APASS LP
FDA Adverse Event
Other
·MEDICREA INTERNATIONAL·Product code MNI·June 15, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
XPS® BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·September 8, 2017
HMO 71000-J#QUADROX-1 ADULT + FILTER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 3, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWF·July 16, 2015
HQC 16602-3#HL-SET, OFFENES SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 19, 2014
ACCY EF201 IPC FOOT CONTROL ROHS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·September 9, 2014
DESCRIPTION FROM THE CUSTOMER REPORT:
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 19, 2016
QUADROX-I ADULT WITH INTEGRATED FILTER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 17, 2016
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code EQJ·June 17, 2016