8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ELVI TRIGLYCERIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198697·AK3 Ultra Insert Trial Size 4, 14mm
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
FDA 510(k)
FDA Class 2
·General Hospital
Praxiject 0.9% NaCl
FDA 510(k)
FDA Class 2
·General Hospital
DENTAL AMALGAM
FDA Adverse Event
Injury
·Product code EJJ·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 22, 2015
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