42 results · 26ms · Sources: EU EUDAMED, US FDA

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AG-CLASSIC

FDA 510(k)
FDA Class 2 ·Anesthesiology

HOME CARE JELLY

FDA 510(k)
FDA Class 2 ·Neurology

PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 29, 2021

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 27, 2024

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 6, 2020

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 23, 2013

SETROX S 53

FDA Adverse Event
Death ·BIOTRONIK SE & CO. KG·Product code NVZ·April 22, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 25, 2022

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 26, 2024

CAPIOX FX HOLLOW FIBER OXYGENATOR WITH HARDSHELL RESERVOIR, ARTERIAL FILTER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 10, 2023

CAPIOX FX25

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·July 18, 2023

CAPIOX FX15 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 3, 2025

CAPIOX CUSTOM PACK

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DTZ·June 10, 2023

CAPIOX CUSTOM PACK

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 10, 2023

CAPIOX FX15 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 25, 2023

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 23, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2022

CAPIOX®FX

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 13, 2024