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FDS INTIMATE AND INTIMATE WARMING LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NAVILYST MEDICAL

FDA Adverse Event
Malfunction ·NAVILYST MEDICAL·Product code LJS·October 19, 2011

UNKNOWN SOLITAIRE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·June 8, 2020

PIPELINE

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·June 8, 2020

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·June 8, 2020

PIPELINE FLEX EMBOLIZATION DEVICE

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 20, 2022

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Death ·EV3 NEUROVASCULAR·Product code OUT·August 6, 2014

Amplion Care Assurance

FDA UDI
AMPLION CLINICAL COMMUNICATIONS, INC.·00850016398444·Firmware for Duty Station (DS), Version 81B5

Amplion Care Assurance

FDA UDI
AMPLION CLINICAL COMMUNICATIONS, INC.·00850016398451·Firmware for Duty Station (DS), Version F886

ANGIODYNAMICS

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code OEZ·December 19, 2016

ANGIODYNAMICS

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code DXT·December 19, 2016

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Death ·EV3 NEUROVASCULAR·Product code OUT·August 6, 2014

NAVILYST MEDICAL / NAMIC

FDA Adverse Event
Malfunction ·NAVILYST MEDICAL·Product code FPA·November 24, 2010

PIPELINE FLEX EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 20, 2022

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Death ·EV3 NEUROVASCULAR·Product code OUT·August 6, 2014

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Death ·EV3 NEUROVASCULAR·Product code OUT·August 6, 2014

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 5, 2023

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 8, 2019

MICRO VISION

FDA UDI
FGX INTERNATIONAL INC.·00887661173485·