9 results
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26ms
·
Sources: EU EUDAMED, US FDA
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
FDA 510(k)
FDA Class 1
·Microbiology
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080925·MESH 905-409 PYRM 10 X 14 OVOID X 9MM
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856458·MESH 905-409 PYRM 10 X 14 OVOID X 9MM
TRANSDUCER PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FACTOR IX DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 9, 2013
UNKNOWN DEPUY HEAD BALL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 19, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 1, 2014
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