9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOWIRE AND FLOMAP
FDA 510(k)
FDA Class 2
·Cardiovascular
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080932·MESH 905-411 PYRM 10 X 14 OVOID X 11MM
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856465·MESH 905-411 PYRM 10 X 14 OVOID X 11MM
CHEMOPLUS GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
FACTOR XI DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 9, 2013
ALTRX +4 NEUT 40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 19, 2010
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·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