7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
RHINOTHERM ULTRA 2
FDA 510(k)
FDA Class 1
·Anesthesiology
ALCIDE REN NEW-D
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
FDA 510(k)
FDA Class 2
·Cardiovascular
LCS COMPLETE LO PRO POLPAT LG+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 3, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·November 5, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013