7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FIAX IGG TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 26, 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code HSB·November 7, 2012
LIGACLIP**
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·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