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

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ENZA-A Titanium ALIF

FDA 510(k)
FDA Class 2 ·Orthopedic

MYSPINE MC VERTEBRA L04

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018

UNITY NETWORK ID

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRAUSON BONE PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

REDUCTION CANNULATED PEDICLE SCREW 5X45

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023

MYSPINE S01 DRILL BASED GUIDE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018

MYSPINE-MC DRILL GUIDE L03

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023

MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011

AUTOPULSE RESUSCITATION SYSTEM MODEL 100

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 9, 2013

ONE TOUCH ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·September 23, 2008

NEOCIS GUIDANCE SYSTEM

FDA Adverse Event
Injury ·NEOCIS INC.·Product code PLV·September 13, 2019

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025

MYSPINE UNILATERAL LEFT GUIDE S01

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024

MYSPINE MYSPINE MC DRILL BASED GUIDE L04

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020

ALINITY S HBSAG REAGENT KIT

FDA Adverse Event
Injury ·ABBOTT IRELAND·Product code QHM·October 4, 2022

ALINITY S HBSAG REAGENT KIT

FDA Adverse Event
Injury ·ABBOTT IRELAND·Product code QHM·November 29, 2022

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024