7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CILCO DIAMOND KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
Dilapan-S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Rapid Surgical Plan (RSP-SW-001)
FDA 510(k)
FDA Class 2
·Radiology
PLM A+ SPANISH DEVICS
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 14, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 19, 2012
ADVIA CENTAUR
FDA Adverse Event
Injury
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·September 22, 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