23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SCORPIO NRG KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN POROCOAT HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DANEK PLATE AND SCREW
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code HRS·June 4, 1999
DANEK PLATE AND SCREW
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code JDN·June 4, 1999
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018
INFUSE-A-PORT
FDA Adverse Event
Injury
·HORIZON MEDICAL PRODUCTS, INC.·Product code LJT·December 9, 1998
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·April 22, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 19, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 28, 2018
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 18, 2019
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - 8010379·Product code LPH·July 1, 2015
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018