10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ORAL AIRWAYS
FDA 510(k)
FDA Class 1
·Anesthesiology
NA
FDA UDI
Zimmer, Inc.·00889024273658·
Uroview FD II
FDA 510(k)
FDA Class 2
·Radiology
AT HOME DRUG TEST, MODEL 9133 T
FDA 510(k)
FDA Unclassified
·Unknown
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·April 30, 2014
ENTRUST VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
NONE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
STANDARD INSERTION HANDLE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code FZX·May 7, 2013
AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code FZX·May 7, 2013
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018