9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 V8D
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDI·May 23, 2022
REMESENSE
FDA 510(k)
FDA Class 2
·Dental
E-CUBE i7
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 19, 2014
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 22, 2010
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·December 20, 2012
Basic Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014