20 results · 22ms · Sources: EU EUDAMED, 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