32 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STA- NeoPTimal
FDA 510(k)
FDA Class 2
·Hematology
iTero Element 5D Plus US cart configuration
FDA UDI
Align Technology, Inc.·00816063020707·Scanner, cart configuration
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
FDA 510(k)
FDA Class 2
·Radiology
FATHOM 16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 7, 2025
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·June 23, 2025
FATHOM -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·March 19, 2025
FATHOM? -16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·November 6, 2025
FATHOM -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 6, 2024
FATHOM -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 3, 2024
FATHOM -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 3, 2024
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 14, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 12, 2026
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·June 16, 2025
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 12, 2025
FATHOM -16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·March 17, 2025
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 22, 2025
FATHOM? -16
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 15, 2025
FATHOM? -16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 22, 2025