9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BILIRUBIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223340·Cervical Rasp 8x16x13
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268223340·
HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CHECKMATE SMALL BONE FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
SPINE IMPLANT
FDA Adverse Event
Injury
·Product code GZB·November 7, 2012
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·August 16, 2007
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