9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CARDIAC ELEVATOR
FDA 510(k)
FDA Class 1
·Cardiovascular
UniTip Catheter
FDA UDI
Unisensor AG·07640172972359·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972366·
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
ORTHODONTIC CERAMIC BRACKETS
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
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 7, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2015
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