20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Benesta Hysteroscope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMPLANT-ONE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CAPRI APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 26, 2023
BALL HEADS: BIPOLAR HEAD Ø28X51
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWY·April 7, 2022
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 22, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 24, 2013
CVC KIT: 2-LUMEN 15 FR X 27 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code MSD·July 20, 2011
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 30, 2022
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 23, 2026
MPACT ACETABULAR SHELL Ø46 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 6, 2022
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 20, 2026
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 24, 2026
CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 9, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 19, 2025
VERSAFITCUP CC TRIO ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 22, 2026
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 2, 2024
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021