8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
VERASENSE for Zimmer Biomet Persona
FDA 510(k)
FDA Class 2
·Neurology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·October 8, 2010
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020