9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
THE VENUS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Reusable and Self-Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
THOR ANTERIOR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·April 9, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL 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