7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ECA CREAM
FDA 510(k)
FDA Class 2
·Neurology
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
FDA 510(k)
FDA Class 2
·General Hospital
Coolief Radiofrequency Generator (CRG) System
FDA 510(k)
FDA Class 2
·Neurology
PULSE GEN MODEL 104
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 16, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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