8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
VENTREZYME T4 IMMUNOASSAY T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUALGUARD
FDA 510(k)
FDA Class 2
·Anesthesiology
ORAVIVE TOOTH REVITALIZING PASTE
FDA 510(k)
FDA Class 2
·Dental
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2014
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·November 20, 2012
HYPO PACK BY TERUMO
FDA Adverse Event
Malfunction
·TERUMO·Product code DWF·September 10, 2010
FULL OSSEOTITE IMPLANT 5 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 25, 2023
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