10 results
·
33ms
·
Sources: EU EUDAMED, US FDA
MCT MEDICAL BROWNE UROSCAN URODYNAMIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vivid Electrode Tip #2
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724B8805040·
NA
FDA UDI
STRYKER CORPORATION·07613327063639·Cold Knife, Hook
PIONEER LOWTOP SPINAL ROD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Mission Lipid Panel Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PUMP IN STYLE
FDA Adverse Event
Other
·MEDELA, INC·Product code HGX·October 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·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