8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ELVI ALKALINE PHOSPHATATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198680·AK3 Ultra Insert Trial Size 4, 13mm
SiteSeal Femoral Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2014
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 16, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 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