10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Scivita 4KINSIGHT ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLOOD-PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·October 8, 2008
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 16, 2020
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·November 5, 2008
GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·August 17, 2011
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 11, 2013
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 19, 2025