8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HOOKS #'S 7600,7602,7603,7616
FDA 510(k)
FDA Class 1
·Ophthalmic
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
Optilite IgA Kit
FDA 510(k)
FDA Class 2
·Immunology
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·July 14, 2015
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014
PFC SIGMARP CV TB/IN S4 10.0
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·October 16, 2012
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 10, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018