7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FACTOR II DEFICIENT SUBSTRATE PLASMA
FDA 510(k)
FDA Class 2
·Hematology
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 27, 2014
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 15, 2012
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·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