42 results · 31ms · Sources: EU EUDAMED, US FDA

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TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK

XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADC QS/IPD WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MPRI·Product code DTB·May 14, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 1, 2011

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2017

BD LUER SLIP¿ TUBERCULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2023