7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
AMES TDA DISOPYRAMIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FIBER OPTIC ADAPTER CAT#60-0898
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VITEK 2 GRAM POSITIVE LINEZOLID
FDA 510(k)
FDA Class 2
·Microbiology
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 14, 2012
R3
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE·Product code JDH·September 13, 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