10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXILINK (SMALL, MEDIUM, LARGE)
FDA 510(k)
FDA Class 2
·Cardiovascular
BINAXNOW INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
da Vinci Xi Hasson Cone
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·June 27, 2019
NGAGE NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·February 9, 2018
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Enforcement
Class II
·Terminated·R82 A/S·May 22, 2019
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·January 7, 2011
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·July 23, 2014
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Recall
Terminated
·Product code INM·March 28, 2019