8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOTEC ACT I SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
HEMOSIL FACTOR XII DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
Silk Road Acccess Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY PATELLA (NOT REMOVED)
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 2, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012
PUMP MMT-722NAL PRDGM INSULIN CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 20, 2010
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·January 24, 2013
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