7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
GOULD MODEL IM3000-IM3100 BATTERY POWER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO STRYKER PAINPUMP2
FDA 510(k)
FDA Class 2
·General Hospital
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
FDA 510(k)
FDA Class 2
·Radiology
SYSTEM 7 RECIP SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·May 23, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 13, 2012
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·September 8, 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