20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JTS EXTENDEABLE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Rejuvapen NXT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JTS UNIT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018
JTS COIL
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020
JTS DRIVE UNIT SET
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 8, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 11, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 10, 2010
JTS DRIVE UNIT SET
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 15, 2022
PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018
JTS DRIVE UNIT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 21, 2019
JTS DRIVE UNIT SET
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·May 27, 2022
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·July 24, 2014
JTS DRIVE UNIT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 8, 2020
JTS DRIVE UNIT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 29, 2020
CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·June 25, 2015
DISTAL FEMUR JTS
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·July 18, 2019
JTS DRIVE UNIT SET
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 28, 2022
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018