9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
FDA 510(k)
FDA Class 2
·Radiology
iTero Lumina Pro
FDA UDI
Align Technology, Inc.·00816063022657·iTero Lumina Pro US Scanning Unit
PHLEBOTEST 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
ALAMO P
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
TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIO VASCULAR·Product code MIH·November 6, 2008
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·August 17, 2011
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 3, 2013
BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·November 20, 2022