7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KARAYA GUM POWDER, OSTOMY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DURAMAX REUSABLE OXIMETRY SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 12, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 11, 2010
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·December 12, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020