38 results · 23ms · Sources: EU EUDAMED, US FDA

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HD Lumbar Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

KOREBALANCE (KINESTHETIC ABILITY TRAINER)

FDA 510(k)
FDA Unclassified ·Unknown

SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021

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·December 13, 2024

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·December 3, 2024

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
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·October 31, 2024

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 4, 2024

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

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

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