10 results
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35ms
·
Sources: EU EUDAMED, US FDA
QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
FDA 510(k)
FDA Class 1
·Dental
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EBI XFIX OPTIROM KNEE FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC TIBIA PS MOD INSRT SZ 3 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 29, 2024
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·January 23, 2013
EXCELLENCE+
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 17, 2010
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 14, 2014
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
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