9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
FOAM SLIPPERS
FDA 510(k)
FDA Class 1
·Physical Medicine
HIGH V+
FDA 510(k)
FDA Class 2
·Orthopedic
WDS, SIZE 2 AND SIZE 2
FDA 510(k)
FDA Class 2
·Dental
MALLORY/HEAD - PF ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2017
QUANTUM? MAVERICK?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 21, 2014
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·July 19, 2007
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 26, 2012
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 28, 2018
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