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FDA 510(k)
FDA Class 2 ·Cardiovascular

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 15, 2024

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 22, 2020

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 21, 2020

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 1, 2022

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 16, 2022

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FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·November 17, 2023

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 1, 2022

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 10, 2026

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 12, 2025

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 24, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 25, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 13, 2021

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FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 31, 2020

CAPIOX FX05

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 27, 2020

CAPIOX FX05

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 25, 2020

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FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 31, 2022