8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
FDA 510(k)
FDA Class 2
·Immunology
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
THROMBO-TEST (X)
FDA 510(k)
FDA Class 2
·Hematology
V-Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 23, 2014
SCORPIO NRG X3 PS TIBIAL INSERT #3 12MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·November 2, 2012
ATLAS PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 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