23 results · 33ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SONEX HEALTH, Inc

FDA registration
SONEX HEALTH, Inc·2 products·🇺🇸 United States

SX-One MicroKnife

FDA UDI
SONEX HEALTH, INC.·00860002094700·SX-One MicroKnife is rebranded as UltraGuideCTR...

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·August 1, 2023

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·July 25, 2023

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·July 29, 2025

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·January 26, 2024

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·June 29, 2023

ULTRAGUIDE TFR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·May 17, 2023

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·May 19, 2023

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 24, 2023

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 24, 2022

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 24, 2023

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 11, 2022

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 11, 2022

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 11, 2022

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·October 24, 2023

ULTRAGUIDECTR

FDA Adverse Event
Injury ·SONEX HEALTH·Product code LXH·January 15, 2025

SONEX ULTRAGUIDE CTR

FDA Adverse Event
Injury ·SONEX HEALTH, INC.·Product code LXH·January 23, 2024

ULTRA GUIDE CTR SONNEX KNIFE

FDA Adverse Event
Malfunction ·SONEX HEALTH, INC.·Product code LXH·March 8, 2024

SX-One MicroKnife

FDA Recall
Terminated ·SONEX HEALTH LLC·Product code LXH·June 29, 2022