35 results · 37ms · Sources: EU EUDAMED, US FDA

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Splintek Inc.

FDA registration
Splintek Inc.·1 product·🇺🇸 United States

SleepRight

FDA UDI
Splintek Inc.·00692121035513·SleepRight Snore Aid is intended for use by adu...

SleepRight

FDA UDI
Splintek Inc.·00692121035438·The SleepRight Select-Comfort Dental Guard is i...

SleepRight

FDA UDI
Splintek Inc.·00692121032062·The SleepRight Ultra-Comfort Dental Guard is in...

SleepRight

FDA UDI
Splintek Inc.·00692121032055·The SleepRight Secure-Comfort Dental Guard is i...

SleepRight

FDA UDI
Splintek Inc.·00692121035216·SleepRight ProRx Custom-Fit Dental Guard is ind...

SleepRight

FDA UDI
Splintek Inc.·00692121032246·The SleepRight Dura-Comfort Dental Guard is ind...

SMARTLOAD

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·December 14, 2021

ARTHREX FLIP CUTTER

FDA Adverse Event
Malfunction ·ARTHREX INC·Product code GEI·February 22, 2018

ENDOWRIST

FDA Adverse Event
Injury ·INTUITIVE SURGICAL, INC·Product code NAY·May 13, 2023

FORCE FEEDBACK

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 13, 2026

TENACULUM FORCEPS INSTRUMENT

FDA Adverse Event
Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·March 18, 2015

ENDOWRIST

FDA Adverse Event
Injury ·INTUITIVE SURGICAL, INC·Product code NAY·November 21, 2021

TECNIS SIMPLICITY

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·October 3, 2024

LEAD MODEL 304

FDA Adverse Event
Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·June 29, 2023

NONE

FDA Adverse Event
Malfunction ·MEDICAL ACTION INDUSTRIES, INC.·Product code LRS·November 20, 2013

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·February 25, 2026

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·March 11, 2025

SMARTLOAD

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·July 12, 2024

SMARTLOAD

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·January 11, 2022