7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PHASE II CORTISOL KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
FDA 510(k)
FDA Class 1
·Microbiology
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 28, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 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