12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SURGISCRIBE MARKING PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIPTER X-1 COMPACT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip Catheter
FDA UDI
Unisensor AG·07640172973769·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971758·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971765·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971772·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971789·
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 20, 2012
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2014
*
FDA Adverse Event
Malfunction
·ABIOMED·Product code KFM·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