22 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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