25 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ALERE INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
MEDICAL IMAGE DIGITIZER, MODEL 2908
FDA 510(k)
FDA Class 2
·Radiology
ERKA. PERFECT-ANEROID
FDA 510(k)
FDA Class 2
·Cardiovascular
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 1, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 29, 2013
TOTAL PROTEIN GEN.2
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEK·June 20, 2011
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2016
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
BD PLASTIPAK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·August 26, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019
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
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2024