29 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·October 17, 2016
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·July 2, 2014
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·January 18, 2017
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
FDA 510(k)
FDA Class 2
·Neurology
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
BCS TIBIA BASE PLATE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·May 3, 2013
5FX60CM SNGL PRO LINE CT
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·August 19, 2014
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 10, 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