196 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERSAFITCUP CC TRIO
FDA 510(k)
FDA Class 2
·Orthopedic
AMISTEM H CEMENTLESS STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 11, 2014
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 31, 2020
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 4, 2019
VERSAFITCUP CC TRIO ACETABULAR SHELL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2017
AMISTEM H, HA COATED STEM SIZE 5 STD
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2017
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 12, 2013
QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JDI·July 29, 2015
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 11, 2019
VERSAFITCUP CC CUP IMPACTOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code LXH·November 21, 2014
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2019
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 18, 2020
VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2018
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·December 5, 2023
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 12, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 29, 2021
AMISTEM H, HA COATED STEM SIZE 6 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2016
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 18, 2017