8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CEB
FDA 510(k)
FDA Class 1
·Microbiology
CONTOUR SE MICROSPHERES
FDA 510(k)
FDA Class 2
·Cardiovascular
ART-Plan (v.2.2.0)
FDA 510(k)
FDA Class 2
·Radiology
SYNCHRON® CK 2 X 400
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·May 10, 2011
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·May 27, 2014
SPIROS CONNECTOR
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code FPA·June 1, 2010
DELTA CER HEAD 12/14 36MM +5
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·November 15, 2012
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