23 results · 22ms · Sources: EU EUDAMED, 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