7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FIAX IGM TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
Teleport XT Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX LIQUID PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 25, 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code HSB·November 7, 2012
LIGACLIP*MCA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·September 12, 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