7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
UR/RITE SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RT016 INSPIRATORY FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
HEMADERM
FDA 510(k)
FDA Unclassified
·Unknown
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BD·Product code NGT·May 21, 2014
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 12, 2012
SYNVISC ONE (SYNVISC ONE)
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 8, 2015
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