7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SILIMED TISSUE EXPANDER
FDA 510(k)
FDA Unclassified
·Unknown
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
FDA 510(k)
FDA Class 2
·Cardiovascular
Percuvance Percutaneous Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
GOODBABY·Product code IOR·February 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·February 2, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 5, 2014
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