25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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