7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STRIPREADER MICROELISA SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SPIROTEL, MODEL 29-1020
FDA 510(k)
FDA Class 2
·Anesthesiology
DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOCKING CALCANEAL PLATE SHORT-LEFT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code LXT·May 26, 2014
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 9, 2012
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2015
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