38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Element System with IBT Electrodes
FDA 510(k)
FDA Class 2
·Neurology
GMK RESUFACING PATELLA SIZE 4
FDA 510(k)
FDA Class 2
·Orthopedic
TRICOS T RESORBABLE BONE SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 7, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023
UNKNOWN BURR HOLE RING
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 15, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
2520274-2013-03519
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·June 17, 2013
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
LAG SCREW, STST 10.5X95MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 21, 2010
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2017
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2020
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2023
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 4, 2023