9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
KEYFILL
FDA 510(k)
FDA Class 2
·Anesthesiology
GC Initial™
FDA UDI
Gc America Inc.·15400556709372·GC Initial™ PC Pellets Opaque Op-3, 5pcs. X 2
GC Initial™
FDA UDI
Gc America Inc.·J0228720531·GC Initial™ PC Pellets Opaque Op-3, 5pcs. X 2
LINE CHARGER MODEL LC-100
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTBLOCK PAIN PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CS300
FDA Adverse Event
Injury
·DATASCOPE CORP·Product code DSP·April 17, 2014
PUMP MMT-522LNAP PRDGM INS PL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·October 8, 2010
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·December 11, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015