7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DAC-CEL HCG-MCA KIT RD52
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·May 23, 2014
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·November 14, 2012
PROMOTE PLUS CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 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