11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
RUBY KNIVES FOR OPHTH. SURGERY
FDA 510(k)
FDA Class 1
·Ophthalmic
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
FDA 510(k)
FDA Class 2
·Dental
LIAISON 25 OH VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 14, 2012
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2015
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 6, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 6, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 6, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 6, 2011
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