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

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ENCORE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MICROLIFE DIGITAL UNDERARM THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

M2376A PHILIPS DEVICE LINK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

2027971-2021-133680

FDA Adverse Event
Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·November 25, 2021

U-BLADE SET, TI GAMMA3 10.5X100MM

FDA Adverse Event
Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 29, 2013

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 20, 2011

GE OEC 2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

GMK SPHERE FEMORAL COMPONENT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

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

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

3005180920-2018-00587

FDA Adverse Event
Injury ·July 31, 2018

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2017