26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BrainView QEEG Software
FDA 510(k)
FDA Class 2
·Neurology
MONT BLANC PEDICLE SCREW SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED ELECTROSURGICAL ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023
CONTOUR TS TEST STRIPS (10)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008
A127 EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 11, 2011
ESSURE
FDA Adverse Event
Injury
·CONCEPTUS INC.·Product code HHS·July 2, 2013
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 3, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2023
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2025
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2024