10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Intradermal Adapter
FDA 510(k)
FDA Class 2
·General Hospital
PIONEER PLUS CATHETER, MODEL PLUS 120
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 6, 2011
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·August 21, 2023
BD¿ NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023