51 results · 29ms · Sources: EU EUDAMED, US FDA

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qER

FDA 510(k)
FDA Class 2 ·Radiology

CORTRAK* Enteral Access System

FDA UDI
Avanos Medical, Inc.·00350770456287·Mounting Adapter Kit

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776345518·Spinal Fusion Curette, size 0000

BAYER ADVIA IMS SYSTEM; 200 + 3

FDA 510(k)
FDA Class 2 ·Immunology

NO-POKES NEEDLE SAFETY DEVICE

FDA 510(k)
FDA Class 2 ·General Hospital

JDEVOLUTION PLUS

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 15, 2012

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

SHILEY DISPOSABLE CANNULA LOW PRESSURE

FDA Adverse Event
Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·April 20, 2010

RESOLUTION CLIP CLIPPING DEVICE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 11, 2011

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

ACCU-CHEK FLEXLINK

FDA Adverse Event
Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code FPA·July 2, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 24, 2012

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 2, 2012

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 4, 2012

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·January 21, 2016

UNKNOWN DEEP BRAIN STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 18, 2010

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2025

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 22, 2010