7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WINGED INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
FDA 510(k)
FDA Class 2
·Cardiovascular
EMIT-STM URINE CONTROLS
FDA 510(k)PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·May 27, 2014
MICROSTAAR® INJECTOR
FDA Adverse Event
Malfunction
·Product code KYB·November 14, 2012
ATTAIN LDS LEFT-HEART DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code DQY·June 10, 2015
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023