7 results
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17ms
·
Sources: EU EUDAMED, US FDA
ELECTRIC VIBRATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
IMPULSE HEAT SEALER
FDA 510(k)ANKLE INSTRUMENTS (FREEMAN-SWANSON)
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 26, 2012
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·December 31, 2013
CE INFUSOR LV10, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 19, 2010
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015