22 results · 42ms · Sources: EU EUDAMED, US FDA

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REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO: LONG LENGTH GAMMA NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

JTS UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

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

BIOMET

FDA Adverse Event
Injury ·BIOMET·Product code KWA·April 29, 2013

BIODESIGN 4-LAYER TISSUE GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTM·August 21, 2014

STEALTHSTATION TRIA NAVIGATION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 27, 2011

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