20 results · 23ms · Sources: EU EUDAMED, US FDA

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Wrist Type Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

WELLNESSPRO 2010

FDA 510(k)
FDA Class 2 ·Neurology

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·June 11, 2013

FRESENIUS 2008K

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014

BD NANO¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022

BD ULTRA FINE PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020

PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020

BD ULTRA-FINE¿ MINI PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·February 5, 2019

BD¿ ULTRA-FINE PEN NEEDLES

FDA Adverse Event
Injury ·BECTON DICKINSON AND CO.·Product code FMI·January 24, 2019

RELION PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·March 25, 2021

BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 27, 2018

6MM X 32G PEN NEEDLE (ULTRAFINE MICRO)

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 11, 2021

COBAS 8000 E 801 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 30, 2018

COBAS 8000 E 801 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 30, 2018

COBAS 8000 E 801 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 30, 2018

BD ULTRA FINE¿ PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 18, 2019