229 results · 22ms · Sources: EU EUDAMED, US FDA

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UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT

FDA 510(k)
FDA Class 2 ·Hematology

GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019

GMK SPHERE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 31, 2013

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 31, 2011

FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 3, 2014

GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

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

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2023

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 21, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

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

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 5, 2023