7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PULSAIR I & II
FDA 510(k)
FDA Class 2
·Anesthesiology
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
SIVR56-T KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 27, 2014
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 15, 2012
COBAS C111
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·September 14, 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