9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STRUVA & MEDI
FDA 510(k)
FDA Class 1
·General Hospital
AURADONICS
FDA UDI
AURADONICS INC.·00810033836046·LATEX ELASTICS 5/16" 3.5 oz. - NEON, 10000 ea.,...
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573023547·FLOW TAIN W/TIPS (1.5g)
ELMED Laparoscopic Instruments and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TELEPAX
FDA 510(k)
FDA Class 2
·Radiology
HICKMAN 7F DUAL-LUMEN CV CATHETER
FDA Adverse Event
Injury
·BARD ACCESS SYSTEM, INC.·Product code LJT·March 10, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
COMPACT MONITOR DISPLAY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 13, 2010
Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree.
FDA Recall
Terminated
·Acclarent, Inc.·Product code KTI·January 30, 2012