8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIAGNOSTIC EP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRAN PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 3, 2020
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 4, 2014
SAFESHEATH CSG
FDA Adverse Event
Malfunction
·THOMAS MEDICAL PRODUCTS·Product code DYB·November 5, 2010
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·January 10, 2013
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