32 results
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44ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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16ch Foot/ Ankle SPEEDER
FDA 510(k)
FDA Class 2
·Radiology
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
FDA 510(k)
FDA Class 2
·Cardiovascular
ENSITE VERISMO SEGMENTATION TOOL V.2.0
FDA 510(k)
FDA Class 2
·Radiology
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·July 27, 2011
ASCENDRA DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2013
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 30, 2008
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2025
BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023
VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022
CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2023
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 11, 2025
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 12, 2026
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 10, 2020
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 24, 2020
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022