55 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
FDA 510(k)
FDA Class 1
·Clinical Chemistry
n/a
FDA UDI
Ortho Development Corporation·00822409072293·DAA Modular Canal Finder
HSB - Cement Burn Component
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121178·HSB - Cement Burn Component
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
GUIDANT AXIUS CORONARY SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
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
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·September 21, 2009
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
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·December 14, 2009
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
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·March 9, 2011