23 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HepaFatSmart (V2.0.0)
FDA 510(k)
FDA Class 2
·Radiology
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
RAPIDO CUT-AWAY CUTTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
560 BIO-CONSOLE BASE UNIT
FDA Adverse Event
Death
·MEDTRONIC PERFUSION SYSTEMS·Product code DWA·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025