7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DURAPHASE PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELECTRONIC STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
FDA 510(k)
FDA Class 2
·Cardiovascular
OXFORD UNI TIB BRG MED SZ4
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·June 13, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 15, 2010
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 13, 2012
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·May 21, 2014