20 results · 22ms · Sources: EU EUDAMED, US FDA

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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