32 results · 21ms · Sources: EU EUDAMED, 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