21 results · 24ms · Sources: EU EUDAMED, US FDA

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Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

FDA 510(k)
FDA Class 2 ·Radiology

STATNET, MODEL 3100

FDA 510(k)
FDA Class 2 ·Neurology

REVIVE INTERMEDIATE CATHETER (REVIVE IC)

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

MULTIGEN RADIOFREQUENCY GENERATOR

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GXD·June 27, 2013

PULSE GEN MODEL 103

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code LYJ·October 22, 2014

GUARDIAN

FDA Adverse Event
Malfunction ·A&E·Product code ITJ·July 10, 2006

BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 3, 2024

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

SKINTACT

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·January 25, 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