7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GENERAL PURPOSE COMBINATION PH ELECTRODE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
VenaCure EVLT NeverTouch Procedure Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINOX SMART S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·June 13, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 16, 2010
UNKNOWN LEFT HIP REJUVENATE/ ABGII NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012
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