7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEMAFLO BLOOD TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD K-4000 MICROKERATOME SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CERAMIN BRACKETS Z
FDA 510(k)
FDA Class 2
·Dental
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014
GATEWAY¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·November 7, 2012
UTS¿
FDA Adverse Event
Malfunction
·COOK MEDICAL·Product code KNS·August 11, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015