7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIROS
FDA 510(k)
FDA Class 2
·Anesthesiology
PREP AND OPERATING STAND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
DURACON MEDIUM 2 BASEPLATE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·January 10, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 6, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 7, 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