77 results · 34ms · Sources: EU EUDAMED, US FDA

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BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK HINGE FEMUR SIZE 2 RIGHT

FDA Adverse Event
Injury ·Product code KRO·September 12, 2014

GMK HINGE

FDA 510(k)
FDA Class 2 ·Orthopedic

TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

FDA 510(k)
FDA Class 2 ·General Hospital

GMK HINGE FEMUR SIZE 5 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 4, 2025

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 30, 2025

GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 29, 2020

CHLORAPREP ONE STEP

FDA Adverse Event
Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·April 19, 2021

CHLORAPREP ONE STEP 1.5 ML FREPP

FDA Adverse Event
Injury ·CAREFUSION 213, LLC 0113·Product code OJU·February 28, 2022

GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 6, 2023

GMK-HINGE FEMORAL COMPONENT SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019

GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019

GMK-HINGE FEMORAL COMPONENT SIZE3 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 20, 2021

CHLORAPREP ONE STEP FREPP

FDA Adverse Event
Malfunction ·CAREFUSION 213, LLC 0113·Product code KXF·May 26, 2021

CHLORAPREP ONE STEP

FDA Adverse Event
Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·September 15, 2021

GMK HINGE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026

GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 15, 2020

GMK-HINGE FEMORAL COMPONENT SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·August 16, 2018