54 results · 23ms · Sources: EU EUDAMED, US FDA

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AxSOS 3 AF System and AxSOS 3 Ti System

FDA 510(k)
FDA Class 2 ·Orthopedic

HERMETIC LUMBAR CATHETER, CLOSED TIP

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·September 26, 2016

HERMETIC LUMBAR CATHETER, CLOSED TIP

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·April 24, 2017

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)
FDA Class 2 ·Hematology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2025

MPACT EXTENSION

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 2, 2026

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 18, 2025

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 9, 2019

AMISTEM-P

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 26, 2025

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 19, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 13, 2025

LINER: MPACT FLAT PE HC LINER Ø28/B

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 3, 2022

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code ITI·July 1, 2013

IMPLANTABLE NEUROSTIMULATOR FOR DBS

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 4, 2016