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MODEL J-5 MVO-MONITOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

SJM TRIFECTA VALVE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code LWR·December 21, 2016

FOUNDATION KNEE SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·December 21, 2009

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·February 19, 2025

PIPELINE FLEX EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 10, 2019

PIPELINE FLEX EMBOLIZATION DEVICE

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 10, 2019

EXPORT UNKNOWN

FDA Adverse Event
Injury ·MEDTRONIC, INC·Product code DXE·November 14, 2025

CADD SOLIS HPCA PUMPS

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code MEA·August 11, 2025

AT HOME DRUG TEST PHARATECH

FDA Adverse Event
PHAMATECH·Product code MVO·September 24, 2003

INTERCEPT ORAL

FDA Adverse Event
Other ·ORASURE·Product code MVO·July 31, 2004

PSYCHEMEDICS

FDA Adverse Event
PSYCHEMEDICS·Product code MVO·April 19, 2005

PSYCHEMEDICS HAIR TESTING KIT

FDA Adverse Event
Other ·PSYCHEMEDICS CORP·Product code MVO·April 7, 2005

REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code MVO·June 21, 2013

*

FDA Adverse Event
Injury ·Product code MVO·June 5, 2009

TRIAGE TOX DRUG SCREEN WITH MTD

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code MVO·June 22, 2009

MEDTOXSCAN

FDA Adverse Event
Injury ·MEDTOX DIAGNOSTICS, INC.·Product code MVO·October 22, 2007

*

FDA Adverse Event
PSYCHEMEDICS CORP·Product code MVO·February 2, 2005

PSYCHEMEDICS HAIR TEST

FDA Adverse Event
Injury ·NUMEROUS LOCATIONS·Product code MVO·July 30, 2008

ISCREEN OFD SALIVA TEST

FDA Adverse Event
Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD·Product code MVO·March 9, 2015

SURESTEP COCAINE 300

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code MVO·November 15, 2013