12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
FDA 510(k)
FDA Class 2
·Cardiovascular
inCoris ZI
FDA UDI
SIRONA Dental Systems GmbH·E27662407872·inCoris ZI maxi L F0.5 1 St/pcs.
PLS (POSTERIOR LUMBAR SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SURGICAL MESH POLYMERIC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
CYLOS VR
FDA Adverse Event
BIOTRONIK GMBH AND CO.·Product code NVZ·November 12, 2008
AMREX MS-322
FDA Adverse Event
Injury
·MED ELECTRONICS DYNATRONICS·Product code IPF·September 5, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2013
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
CONTOUR® NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025