44 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Sterilance Press4 Pressure Activated Safety Lancet
FDA UDI
SteriLance Medical (Suzhou) Inc.·16945630108966·Sterilance Press4 Pressure Activated Safety Lan...
STOCKERT COMPACT SYSTEM VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CUSTOM TUBING - SET INC. OXYGENATOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 24, 2015
QUADROX COMPLETE PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 24, 2014
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
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
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
CUSTOM TUBING - SET INCL. HMO 71000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 14, 2015
*
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KNW·April 17, 2013
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·April 26, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 25, 2008
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 22, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 1, 2015
HLM TUBING SET
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 27, 2016